2005-07-04T16:44:00.000-07:00

dapoxetine

Monday, July 04, 2005

Dapoxetine side effects
Dapoxetine treatment is not without side effects, however. These included:

* Nausea in 8.7 percent of men getting low-dose and 20.1 percent of men getting high-dose dapoxetine.
* Headache in 5.9 percent of men getting low-dose and 6.8 percent of men getting high-dose dapoxetine.
* Diarrhea in 6.8 percent of men getting high-dose dapoxetine.
* Dizziness in 6.2 percent of men getting high-dose dapoxetine.

During studies side effects occurred with greater frequency in the dapoxetine 100-mg group (16.1%) compared with the dapoxetine 60-mg (5.6%) and placebo (0.7%) groups. On the basis of this response and acceptable tolerability, the 60-mg dose was selected for the ongoing large-scale study.

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine developed to treat premature ejaculation
A Phase III clinical trial demonstrated that men taking Dapoxetine for the treatment of premature ejaculation ( PE ) experienced significant improvements in sexual function, including ejaculatory control, satisfaction with sexual intercourse for men and their partners, and increases in intravaginal ejaculatory latency time ( IELT ).

According to the American Urological Association, premature ejaculation may be the most common male sexual disorder.
It is estimated that PE may affect 27 percent to 34 percent of men across all age ranges, in contrast to erectile dysfunction, which is estimated to affect 10 percent to 12 percent of all men, who are usually older in age.

The phase III clinical trials studied 2,614 men with premature ejaculation aged 18-77 in monogamous sexual relationships of greater than six months.

Premature ejaculation was defined as persistent or recurrent ejaculation sooner than desired either before or shortly after penetration, typically reflecting an IELT of two minutes or less, over which the sufferer has minimal or no control.

Men in the studies were randomized to receive 30 mg or 60 mg of Dapoxetine over 12 weeks in two identical, double-blind, placebo-controlled, multicenter trials. Patients were asked to take study medication one-to-three hours before intercourse.
Participants had IELT of two minutes or less in at least 75 percent of intercourse episodes occurring during the two-week baseline run-in period prior to treatment.

The studies examined changes from baseline for mean IELT as monitored by a stopwatch; measured the subject's ejaculatory control and sexual satisfaction on a five-point scale from "very poor to very good" and measured the partner's satisfaction with sexual intercourse from "very poor to very good."

The results showed:

- Men taking Dapoxetine 30 mg and 60 mg experienced more than a three-to-four fold increase in mean IELT compared with placebo ( P < 0.0001 at 30 mg and 60 mg ). IELT increased significantly with the first dose of Dapoxetine, and increases in IELT were maintained over the 12-week study period.

- The percentage of men rating control over ejaculation as "fair to very good" increased dramatically for Dapoxetine 30 mg ( 2.5 percent to 51.8 percent ) and 60 mg ( 3.3 percent to 58.4 percent ) compared to placebo ( 3.5 percent to 26.4 percent ).

- The percentage of men rating sexual satisfaction as "good to very good" almost doubled with Dapoxetine 30 mg ( 20.2 percent to 38.7 percent ) and 60 mg ( 22.3 percent to 46.5 percent ), respectively, in comparison to placebo ( 21.6 percent to 24.6 percent ).

- The percentage of partners rating sexual satisfaction as "good to very good" almost doubled with Dapoxetine 30 mg ( 20.4 percent to 39 percent ) and 60 mg ( 24.8 percent to 47.4 percent ), respectively, compared to placebo ( 20.1 percent to 25.2 percent ).

The study also found that Dapoxetine was generally well tolerated, with most side effects of mild-to-moderate severity.
The most common adverse events reported with both 30 mg and 60 mg doses of Dapoxetine were nausea, followed by headache.

An observational study published in 2005 in The Journal of Sexual Medicine found that patient-reported outcome measures ( PROs ), such as control over ejaculation, satisfaction with sexual intercourse and distress are important factors in assessing the benefit of treatments for premature ejaculation in clinical studies. The study found that men with premature ejaculation and their partners reported higher ratings for interpersonal difficulty, lack of control over ejaculation and dissatisfaction with sexual intercourse.

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine and Male Sexual Dysfunction
Sexual Dysfunction and Dapoxetine. A cure for premature ejaculation?

Three common problems in male health are the sexual issues of infertility and impotence, along with enlargement of the prostate (or benign prostatic hyperplasia, also known as BPH).

Infertility
Infertility is defined as the failure of a couple to become pregnant after one year of regular, unprotected intercourse. In both men and women the fertility process is complex, and, in many cases, infertility is caused by a combination of problems in both partners that conspire to prevent conception. About 10% to 15% of couples experience some form of infertility, and, in approximately 40% of these cases, male infertility is the major factor.

Impotence or Erectile Dysfunction (ED)
Impotence or erectile dysfunction is the inability to achieve or maintain a penile erection sufficiently rigid for intercourse, ejaculation, or both. It does not mean that sexual drive or the ability to have an orgasm is affected. Rarely does erectile dysfunction signify a chronic problem.

Benign prostatic hyperplasia (BPH)
Benign prostatic hyperplasia (BPH) is a non-cancerous growth of the prostate gland that makes urination difficult and uncomfortable. The expanding prostate squeezes the urethra, the channel that carries urine from the bladder. Symptoms usually develop around age 50. At age 60, most men will likely have BPH. At age 80, there's an 80% chance of experiencing urination problems caused by BPH.

# posted by shyone72 @ 4:06 PM 0 comments

Medical Treatment of Premature Ejaculation. Is Dapoxetine the first real cure for male premature ejaculation?
No drug is approved by the FDA for the treatment of PE. However, numerous studies have shown that SSRIs and drugs with SSRI-like side effects are safe and effective to treat this condition, and many physicians use these agents for this purpose. SSRIs have been the most successful agents in delaying the too-rapid response in men who experience PE. Desensitizing creams containing local anesthetic agents can also be useful for some men with PE. These agents are not approved by the FDA specifically for this use, but they are believed to be of at least some efficacy and are a minimal-risk option for patients.

If PE relates to ED, then it may resolve if ED is treated successfully. Drugs for the treatment of ED include sildenafil (Viagra), alprostadil (Caverject, MUSE), and, possibly, SSRI antidepressants (if depression is causing the ED). Details on drugs for the treatment of ED are included in the article on impotence (see Erectile Dysfunction). If a patient does not have PE but has depression-related ED only, then use of a drug with minimal adverse sexual effects (incidence <1%) such as bupropion HCl (Wellbutrin) might be a consideration in an effort to avoid creating a problem with delayed ejaculation or even anorgasmia. However, if the patient has significant PE, ED, and depression, than an added benefit of an antidepressant with SSRI side effects is the possibility that the PE will also be helped.

# posted by shyone72 @ 4:06 PM 0 comments

A history of Premature Ejaculation
The history of the patient's PE complaint is very helpful because it ultimately guides the treatment that is best suited to the patient (and his partner). One needs to focus on whether PE is lifelong (ie, primary) or acquired (ie, secondary) and assess the severity of the problem.

For completeness, a general medical history should be taken to screen for other medical conditions that might be relevant. For example, if the patient has angina and this causes fear of a myocardial infarction during sexual activity, he might present with a complaint of PE when the actual underlying problem is his cardiac disease and his mental insecurity regarding his cardiac disease. Resolution of the cardiac problem usually solves the PE, with no specific therapy for the PE. For the purpose of this discussion, the patient is assumed to be healthy, and sexual dysfunction is the only significant problem.

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine
Dapoxetine (3D structure of dapoxetine shown left) was originally an antidepressant and one of the side effects of several antidepressants is retarded ejaculation (an inability to reach orgasm), inability to sustain an erection and/or impotence.

It was pharmacologist Karl Thor who spotted the repositioning potential of Dapoxetine and suggested its indication for premature ejaculation treatment.

Assuming there are now last minute regulatory problems, it is assumed that the drug will be granted a licence for this indication in the near future. Numerous drug companies have seen the potential benefits of reprofiling old drugs rather than starting from scratch with each new disease or disorder.

Premature ejaculation is the most common male sexual dysfunction, affecting as many as one-third of men worldwide at some time in their lives.

If approved by the FDA, dapoxetine hydrochloride would be the first prescription treatment designed specifically to treat PE and will be marketed in the U.S. by Ortho-McNeil Pharmaceutical, Inc.

Dapoxetine, the promised cure for premature ejaculation (PE) could become Viagra Reloaded for men. The US Food and Drug Administration is currently reviewing a New Drug Application for dapoxetine, developed by Johnson & Johnson, which if approved, would be the first prescription product indicated for treating PE.

Dapoxetine data demonstrates that men taking dapoxetine hydrochloride for the treatment of premature ejaculation experienced significant improvements in sexual function, including ejaculatory control, satisfaction with sexual intercourse for men and their partners, and increases in intravaginal ejaculatory latency time (IELT). These data were presented at the 100th Annual Scientific Meeting of the American Urological Association.

If Viagra has made sex possible for men suffering from impotence, a new drug introduced in the United States aims to make it last longer. Much longer...

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine: A Mans Best Friend
Dapoxetine is chemically similar to a family of antidepressants called SSRIs (selective serotonin reuptake inhibitors) & it may be the new Viagra, I can imagine this becoming the next spam boom industry. No longer will our email bow under the pressure of H3rb4l V14gr4 sales pitches (Don't worry though, you should continue to get Nigerian phishing scams)

In related news, still no cure for cancer.

# posted by shyone72 @ 4:06 PM 0 comments

New Drug Application Submitted for Dapoxetine for Premature Ejaculation
MOUNTAIN VIEW, Calif., December 28, 2004 -- ALZA Corporation today announced that it has submitted a new drug application to the U.S. Food and Drug Administration (FDA) for dapoxetine hydrochloride, a new treatment for premature ejaculation (PE). Premature ejaculation is the most common male sexual dysfunction, affecting as many as one-third of men worldwide at some time in their lives.

"Premature ejaculation is a frequent and distinct medical condition that can severely impact quality of life, affecting the physical and emotional well-being of patients and their partners," says James H. Barada, M.D., urologist at the Center for Male Sexual Health, Albany, NY, and board member of the Sexual Medicine Society of North America (SMSNA).

If approved by the FDA, dapoxetine hydrochloride would be the first prescription treatment designed specifically to treat PE and will be marketed in the U.S. by Ortho-McNeil Pharmaceutical, Inc.

ALZA Corporation, headquartered in Mountain View, California, is leading the next generation of drug delivery, with the world's broadest array of technology platforms, including oral, transdermal, implantable, and liposomal technologies. More than 30 products marketed in over 80 countries worldwide now incorporate ALZA's drug delivery technologies.

# posted by shyone72 @ 4:06 PM 0 comments

New drug for treating premature sexual ejaculation is made - Dapoxetine Chloride
Pharmaceutical companies, lea by Johnson & Johnson, have begun testing drugs aimed at treating premature sexual ejaculation.

Johnson's dapoxetine has been under review by the Food and Drug Administration for six months, and industry experts said the drug might soon become the first approved for the condition, which is estimated to affect 15 percent to 30 percent of American men, the Wall Street Journal reported Tuesday.

A major study presented during the American Urological Association annual meeting in San Antonio suggested dapoxetine could help men delay orgasm, the Journal said.

The companies have been encouraged by the $2.5 billion-a-year erectile dysfunction industry. The companies, experts say, are hoping the new treatments will, as did Viagra, represent the next generation of lifestyle drugs, reports the Washington Times.

According to Reuters, only about 20 to 25 percent of the men's partners felt satisfied by sex before the men took the drug but this doubled to 47 percent after the men took the highest dose.

The trial was a phase III clinical trial of 2,614 men, designed to be the last test before seeking U.S. Food and Drug Administration approval.

It is a drug called a serotonin transporter inhibitor.

The companies have worked hard to define just what premature ejaculation is in order to set parameters for testing the drug.

But they anticipate a good market.

The American Urological Association estimates that premature ejaculation affects anywhere between 27 percent and 34 percent of men across all age ranges. Erectile dysfunction, the condition that made Pfizer's impotence drug Viagra into a blockbuster, affects an estimate 10 percent to 12 percent of men.

Researchers working on the drug reported last month that they could define premature ejaculation. They said a man with the condition took 1.8 minutes to ejaculate after beginning intercourse compared to 7.3 minutes for most men.

They call this Intravaginal Ejaculatory Latency Time and is timed by giving the man or his sexual partner a stopwatch.

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine & Viagra
Since the arrival of Viagra, male sexual dysfunction related topics are more open for discussion and debate. Initially erectile dysfunction was a topic hardly known or discussed with confident, but Viagra has changed the way people now perceive about male sexual health related problems. Pfizer's Viagra is a pill commonly used for male erectile dysfunction problem. Viagra has also helped and educated people on common terms related to male sexual problems. Now premature ejaculation, delayed ejaculation, male impotence, erectile dysfunction and other topics have easily make a place in the health dictionary of an individual.

More common than erectile dysfunction, this condition can affect men at any point in their lives, and one in four men experience poor control over ejaculation on a frequent basis. According to published research, 20%–30% of men worldwide are commonly affected by premature ejaculation (PE), yet this medical condition remains a taboo subject in virtually every culture.

Premature ejaculation is defined as persistent or recurrent ejaculation with minimal sexual stimulation before, upon, or shortly after penetration, or before the person wishes, causing distress and embarrassment to one or both partners, potentially affecting sexual relationships and overall well-being. To help overcome the cause of premature ejaculation, ALZA and Johnson & Johnson Pharmaceutical Research & Development, are developing dapoxetine and will seek approval from regulatory authorities around the world.

# posted by shyone72 @ 4:06 PM 0 comments

Drug for Premature Ejaculation
Concluding a sex-filled posting day with some interesting medical news –

A new drug manufactured by Johnson & Johnson designed to help men with treatment for premature ejaculation has passed its first test. The Wall Street Journal reported on Tuesday that a major study presented during the American Urological Association annual meeting in San Antonio suggested the drug dapoxetine could help men suffering from premature ejaculation by delaying orgasm.

The drug supposedly helped men to increase their ejaculation time significantly — from less than one minute to more than three minutes! Can there be nothing that medical science cannot solve with a pill? Couples everywhere can now live it up for another two minutes.

Writing in the Journal of Sexual Medicine, the researchers said they timed ejaculations by giving stopwatches to the sex partners of more than 1,500 men.

Did they ever think that maybe all this premature ejaculation was occurring to these poor men because their partners were in bed holding stopwatches? You try it.

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine Hydrochloride Significantly Improves Premature Ejaculation
SAN ANTONIO, TX -- May 24, 2005 -- The investigational agent dapoxetine hydrochloride is effective for the on-demand treatment of premature ejaculation (PE), researchers announced here May 23rd at the American Urological Association (AUA) Annual Meeting.

Dapoxetine is currently under review by the US Food and Drug Administration. If approved, it would be the first prescription product indicated for the treatment of PE, which is considered the most common male sexual disorder and may affect as many as 25% of men worldwide.

The new findings -- from phase 3 clinical trials -- showed that dapoxetine was associated with increased intravaginal ejaculatory latency time (IELT), improved ejaculatory control, and increased satisfaction with sexual intercourse for men and their partners.

"Our results show for the first time that a medication taken by men on an on-demand basis can significantly improve PE," said principal investigator Jon L. Pryor, MD, chairman and program director of the department of urologic surgery at the University of Minnesota in Minneapolis, Minnesota.

He also emphasized that current methods of PE treatment involve largely behavioral therapy or off-label use of antidepressants, both of which have limited success.

Dr. Pryor presented results in 2,614 men with PE who had been randomized to receive 12 weeks' treatment with 30 mg or 60 mg of dapoxetine in 2 identical, double-blind, placebo-controlled, multicenter trials.

Patients were instructed to take their assigned treatment 1 to 3 hours before anticipated intercourse.

Subjects had IELT of 2 minutes or less in at least 75% of intercourse episodes during the 2-week baseline run-in period prior to treatment. The primary efficacy endpoint was IELT adjusted for baseline as measured by a stopwatch held by the female partner.

The study showed that men taking either dose of dapoxetine had a 3- to 4-fold increase in mean IELT compared with placebo (P < .0001 at both 30 mg and 60 mg doses). Notably, IELT increased significantly with the first dose of dapoxetine, and increases in IELT were maintained throughout the 12-week trial.

In the group treated with 30 mg of dapoxetine, 2.5% rated their control over ejaculation as "fair to very good" before treatment; after treatment, this increased to 51.8%. Similarly, only 3.3% of men treated with the 60 mg dose of dapoxetine rated their control over ejaculation as "fair to very good" before treatment; this increased to 58.4% after treatment. In the placebo cohort, the percentage of men rating control over ejaculation as "fair to very good" increased from 3.5% prior to treatment to 26.4% after treatment.

The percentage of men who rated their sexual satisfaction as "good to very good" nearly doubled after treatment with both doses of dapoxetine (20.2% to 38.7% for the 30 mg dose and 22.3% to 46.5% for the 60 mg dose) compared with placebo treatment (21.6% to 24.6%).

Impressive results were also noted with respect to partners' assessment of sexual satisfaction. In fact, the percentage of partners who rated sexual satisfaction as "good to very good" almost doubled with both doses of dapoxetine compared with placebo.

Dapoxetine was usually well tolerated. The most common treatment-related adverse events were nausea and headache.

The studies were funded by Johnson & Johnson Pharmaceutical Research and Development.

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine - Premature ejaculation drug delays climax
‘The first drug formulated to treat premature ejaculation delayed climax and increased reported satisfaction in a late-stage study, its developer, Johnson & Johnson, said on Monday.

A Phase III clinical trial of 2,614 men showed the drug provided “significant improvements in sexual function, including ejaculatory control, satisfaction with sexual intercourse for men and their partners, and increases in intravaginal ejaculatory latency time,” Ortho-McNeil Pharmaceutical, a unit of J&J, said in a statement.

The drug, called dapoxetine, is being co-developed by J&J’s Alza Corp. and Johnson & Johnson Pharmaceutical Services, LLC units. The company’s Ortho-McNeil Pharmaceutical unit will market the drug in the United States if it receives U.S. Food and Drug Administration approval.’

# posted by shyone72 @ 4:06 PM 0 comments

What is Premature Ejaculation and how does Dapoxetine help cure premature ejaculation?
Premature ejaculation (PE) is the most common sexual dysfunction complaint in men younger than 40 years. Most professionals who treat PE define this condition as the occurrence of ejaculation prior to the wishes of both sexual partners. This broad definition thus avoids specifying a precise duration for sexual relations and reaching a climax, which is quite variable and depends on many factors specific to the individuals engaging in intimate relations. An occasional instance of PE might not be cause for concern, but if the problem occurs with more than 50% of attempted sexual relations, then a dysfunctional pattern usually exists for which treatment may be appropriate.

What is Premature Ejaculation?

Premature Ejaculation is one of the most common forms of male sexual problems which have affected almost every man at some point in life.

Premature Ejaculation is the inability to delay ejaculation to a point which is mutually desirable for both partners. Usually it leads to an unsatisfactory sexual experience for both the partners.

The duration of time for ejaculation is not the true concern during the intercourse but the issue is whether the couple is really satisfied with the activity or not.

What causes it?

Though it is quite common in men, the exact cause of Premature Ejaculation is still unclear. Experience and Psychological factors have been primarily related as contributors to this condition.

Premature Ejaculation often occurs during the first experience with sex and the lack of ejaculatory control combined with anxiety is responsible towards it.

However, psychological factors such as guilt, depression, anxiety, insomnia etc. also result in this situation. Other factors such as stopping alcohol consumption before sex and a long time gap since the last ejaculation equally relate to the condition.

Is there any Solution?

It has been found that premature ejaculation resolves on its own over time without the need for a medical treatment. However, practicing relaxation techniques or using distraction methods can also help you in delaying ejaculation. You may practice techniques like Masters and Johnson Method, Simulation Technique or Squeeze Technique to exercise greater control over your performance. In addition, keeping a check over the alcohol intake and illegal drug usage is also helpful.

# posted by shyone72 @ 4:06 PM 0 comments

On the Horizon
Dapoxetine is well tolerated and improves premature ejaculation, according to the results of a phase 2 multicenter, double-blind, randomized, placebo-controlled, 3-phase crossover trial presented at the 11th World Congress of the International Society for Sexual and Impotence Research in Buenos Aires, Argentina.

"Premature ejaculation is a condition that's not often talked about, and by definition it means having ejaculation too early — before a man can control his ejaculation — such that it causes him or his partner some distress," lead investigator Wayne Hellstrom, MD, told Medscape. Dr. Hellstrom is professor of urology at Tulane University Medical Center in New Orleans, Louisiana, and a member of the Medscape Urology editorial advisory board. "[Premature ejaculation is] very common; well recognized studies claim that up to 30% of men suffer from the condition at one time or another," he said.

According to Dr. Hellstrom, an assessment of premature ejaculation based on the woman's use of a stopwatch during intercourse to measure the time elapsed between penetration and ejaculation (intravaginal ejaculatory latency time [IELT]) is more accurate than assessments based on counted thrusts to ejaculation, or estimations of time elapsed. An IELT of fewer than two minutes is considered to be abnormal, or capable of causing distress.

To evaluate the efficacy and tolerability of dapoxetine compared with placebo, Dr. Hellstrom and colleagues randomized 166 male patients aged 23 to 64 years with a baseline IELT of fewer than two minutes (mean, 1.01 minutes) to a series of three crossover treatment periods with dapoxetine 60 mg, dapoxetine 100 mg, and placebo, each separated by 72-hour washout periods. All subjects were involved in a monogamous relationship lasting at least six months; 130 subjects completed the study.

Results of an intent-to-treat analysis showed that dapoxetine 60 mg and 100 mg significantly increased IELT compared with placebo (2.94 minutes for the 60-mg group and 3.20 minutes for the 100-mg group compared with 2.05 minutes for the placebo group; P < .0001 for both).

Nausea was the most commonly reported adverse event, and it occurred with greater frequency in the dapoxetine 100 mg group (16.1%) compared with the dapoxetine 60 mg (5.6%) and placebo (0.7%) groups.

"There were certain side effects with the higher dose [of dapoxetine], such that 10 patients dropped out of the study — one in the placebo group and 9 in the 100-mg group, mostly due to nausea," noted Dr. Hellstrom. "There were no dropouts in the 60-mg group."

"On the basis of these results — the increase in intravaginal ejaculation time to about three minutes from one minute, and the fact that the 60-mg dose didn't have any adverse effects — Johnson & Johnson decided to use the 60-mg dose in large-scale clinical trials [that are] currently in progress," Dr. Hellstrom said, noting that dapoxetine will likely be available for clinical use in the next six to 12 months.

"As far as quality of life and satisfaction, especially with your partner — I think you're probably going to see studies that come out in the future that look at perception and quality of life, and find less depression, better self-esteem, and improvements in all those kinds of life value parameters in people who have this problem," Dr. Hellstrom noted. "[Premature ejaculation] can cause a lot of distress in a couple, and [dapoxetine therapy] has the potential to help them tremendously."

The investigators report having received funding from Johnson & Johnson, the maker of dapoxetine.

# posted by shyone72 @ 4:06 PM 0 comments

World's first drug to extend intercourse introduced in US: dapoxetine
WASHINGTON, May 24 (AFP) - If Viagra has made sex possible for men suffering from impotence, a new drug introduced in the United States aims to make it last longer. Much longer...

The new wonder medicine named dapoxetine, unveiled at an annual meeting of the American Urological Association Monday, is designed to help millions of men around the world cope with premature ejaculation wreaking havoc on their sex lives.

Although much less publicized than erectile dysfunction, premature ejaculation affects between 27 percent and 34 percent of males of all age groups, according to the association.

By contrast, erectile dysfunction treated by Viagra and similar drugs affects an estimated 10 to 12 percent of all men, usually in the older age group.

This condition is traditionally diagnosed when sperm release occurs two minutes or less into the sexual act, or even before penetration.

"The impact premature ejaculation can have on men and their partners can be devastating for a relationship and, currently, there are no truly optimal therapies for PE," said Doctor Jon Pryor, chief urologist at the University of Minnesota and lead researcher during dapoxetine's clinical trials.

The test involved 2,614 men aged between 18 and 77, who maintained monogamous sexual relationships of more than six months and suffered from premature ejaculation.

Each received 30 milligrams or 60 milligrams of dapoxetine over 12 weeks in two identical placebo-controlled trials.

The results showed the drug helped them lengthen intercourse three to four times. What's more, dapoxetine increased their staying power with the first dose and helped maintain the increases over the whole study period.

The percentage of study participants rating their control over ejaculation as "fair to very good" increased from 2.5 percent to nearly 52 percent for those taking 30-milligram doses of dapoxetine. For those taking 60 milligrams, it shot up from 3.3 percent to more than 58 percent, the trials showed.

The share of pill takers calling their satisfaction from intercourse "good to very good" almost doubled, as did the satisfaction of their female partners.

The most common adverse side effect reported with both doses were nausea and headache.

Pryor called the results "compelling."

"They demonstrate that, for the first time, a medicine can be taken by men on an on-demand basis and provide significant improvement in their PE condition," he said in a statement.

The US Food and Drug Administration is reviewing an application for the pioneer drug, which was developed by Ortho-McNeil Pharmaceutical, an affiliate of Johnson and Johnson.

# posted by shyone72 @ 4:06 PM 0 comments

Pathophysiology of Premature Ejaculation
PE is believed to be a psychological problem and does not represent any known organic disease involving the male reproductive tract or any known lesions in the brain or nervous system. The organ systems directly affected by PE include the male reproductive tract (ie, penis, prostate, seminal vesicles, testicles, and their appendages), the portions of the central and peripheral nervous system controlling the male reproductive tract, and the reproductive organ systems of the sexual partner (for the purpose of this discussion, the partner is assumed to be female) that may not be stimulated sufficiently to achieve orgasm. If the PE occurs so early that it happens before commencement of sexual intercourse and the couple is attempting pregnancy, then pregnancy is impossible to achieve unless artificial insemination is used. Perhaps the most affected organ system is the psyche of the partners. Both partners are likely to be dissatisfied emotionally and physically by this problem.

Frequency :

In the US : The prevalence rate of PE in American males is estimated to range from 30-70%.

Internationally: Estimates for European countries and India mirror the prevalence in the United States . The prevalence in other parts of Asia , Africa , Australia , and elsewhere is unknown.

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine effective for premature ejaculation disorder
According to the results of a phase 2 multicenter, double-blind, randomized, placebo-controlled, 3-phase crossover trial presented at the 11th World Congress of the International Society for Sexual and Impotence Research in Buenos Aires, Argentina Dapoxetine is well tolerated and improves premature ejaculation.

To evaluate the tolerability and efficacy of dapoxetine compared with placebo, Dr. Hellstrom and his team randomized 166 male patients aged 23 to 64 years with a baseline intravaginal ejaculatory latency time (IELT) of fewer than two minutes (mean, 1.01 minutes) to a series of three crossover treatment periods with dapoxetine 60 mg, dapoxetine 100 mg, and placebo, each separated by 72-hour washout periods. All subjects were involved in a monogamous relationship lasting at least six months; 130 subjects completed the study.

Results of an intent-to-treat analysis showed that dapoxetine 60 mg and 100 mg significantly increased IELT compared with placebo (2.94 minutes for the 60-mg group and 3.20 minutes for the 100-mg group compared with 2.05 minutes for the placebo group; P < .0001 for both).

"On the basis of these results — the increase in intravaginal ejaculation time to about three minutes from one minute, and the fact that the 60-mg dose didn't have any adverse effects — Johnson & Johnson decided to use the 60-mg dose in large-scale clinical trials [that are] currently in progress," Dr. Hellstrom said, noting that dapoxetine will likely be available for clinical use in the next six to 12 months.

Before treatment, only about 3 percent of the men reported at least fair control over ejaculation. After placebo treatment, a surprising 26.4 percent of men reported fair control. Even so, more men reported fair-or-better control after taking dapoxetine: 51.8 percent in the low-dose group, and 58.4 percent in the high-dose group.

Dapoxetine data demonstrates that men taking dapoxetine hydrochloride for the treatment of premature ejaculation experienced significant improvements in sexual function, including ejaculatory control, satisfaction with sexual intercourse for men and their partners, and increases in intravaginal ejaculatory latency time (IELT)*. These data were presented at the 100th Annual Scientific Meeting of the American Urological Association.

# posted by shyone72 @ 4:06 PM 0 comments

Understanding Dapoxetine - What is Premature Ejaculation?
Premature ejaculation is defined as persistent or recurrent ejaculation with minimal sexual stimulation before, upon, or shortly after penetration. This condition is traditionally diagnosed when sperm release occurs two minutes or less into the sexual act, or even before penetration.

Lack of ejaculatory control is probably one of the most common male sexual dysfunctions.
It is believed that premature ejaculation is usually caused by emotional or psychological factors.

Although much less publicized than erectile dysfunction, Premature ejaculation is one of the most common male sexual disorders, it remains widely un-diagnosed and un-treated. Most physicians do not investigate for PE and some men find it difficult to hear they have a sexual impedimentand they are extremely reluctant to talk about the condition.

PE can have a significant impact on many aspects of a man's life. It can affect his and his partner's sexual satisfaction and their ability to build and maintain relationships – both sexual and non-sexual – and can impact a man's general sense of self-confidence.

According to American Urological Association, premature ejaculation affects between 27 percent and 34 percent of males of all age groups. By contrast, erectile dysfunction treated by Viagra and similar drugs affects an estimated 10 to 12 percent of all men, usually in the older age group.

An observational study published in the May 2005 issue of The Journal of Sexual Medicine found that patient-reported outcome measures (PROs), such as control over ejaculation, satisfaction with sexual intercourse and distress are important factors in assessing the benefit of treatments for PE in clinical studies. Beside lack of control over ejaculation and dissatisfaction with sexual intercourse, the study found that men with PE and their partners reported higher ratings for interpersonal difficulty.

# posted by shyone72 @ 4:06 PM 0 comments

Pharmaceutical Product Devt's Dapoxetine Raises Hopes, Shares
CHARLOTTE -(Dow Jones)- The first drug expected out of Pharmaceutical Product Development Inc.'s (PPDI) proprietary pipeline has caught a lot of attention on both Wall Street and Main Street.

Dapoxetine, considered the first drug specifically for premature ejaculation, has been called "the next Viagra" by some industry analysts. And it has generated nationwide attention in the popular media, especially for Johnson & Johnson (JNJ), which will market the drug under license from Pharmaceutical Product Development, or PPD as it is called.

With all of the buzz, shares of PPD are up about 14% this year. Recently trading at $47.79, shares of the Wilmington, N.C., company are near an all-time high of $50.68 set in April.

But some analysts believe the potential benefit from dapoxetine is fully baked into shares, even though the drug hasn't yet received approval by the Food and Drug Administration and even though PPD hasn't revealed financial terms of its agreement with Johnson & Johnson to market the drug.

Indeed, Sentinel Mid-Cap Growth fund manager Robert Lee said he recently sold the fund's shares of PPD due to the run-up in price. The benefit of dapoxetine is getting fully reflected in the stock price, he said.

R.W. Baird analyst Eric Coldwell, a bull on dapoxetine's prospects for more than a year, agrees.

"I'm excited about the drug and I think if anybody can pull this off, it's PPD," said Coldwell in an interview. "I do think that the excitement for the compound has gone from unrealistically pessimistic two years ago to unrealistically optimistic right now."

Coldwell downgraded shares in November, when they traded around $43, to neutral from outperform. His one-year $48 price target for PPD assumes a valuation of about $6 a share for dapoxetine, according to his most recent research report.

PPD has been a contract researcher for 19 years but in 1997 established a risk-sharing business, called its discovery segment, to help pharmaceutical and biotechnology clients develop new medications.

Dapoxetine, developed with Eli Lilly & Co. (LLY) until PPD bought the remaining rights in December 2003, was its first area of focus.

PPD Chairman and Chief Executive Fred Eshelman, in announcing the $65 million purchase from Lilly 18 months ago, said peak annual dapoxetine sales of $750 million were included in the financial model.

But Merrill Lynch, citing a high level of physician interest in the drug, last month boosted its estimates for Johnson & Johnson's worldwide sales of dapoxetine to as much as $1.45 billion by 2008.

The firm doesn't cover PPD, but in a recent research report on J&J, Merrill Lynch analyst Katherine Martinelli likened dapoxetine to Pfizer Inc.'s (PFE) Viagra, which generated nearly $1 billion in sales its first year on the market. Premature ejaculation, or PE, is more common than erectile dysfunction, and affects 20% to 30% of U.S. men, the analyst said in the report.

In an interview this week, however, Eshelman deferred to Johnson & Johnson any comment on dapoxetine's market size or estimated peak sales, including any comment on the previous estimate of $750 million peak annual sales.

"If and when this drug is approved and actually launched, then some kind of forecasting will be material to PPD and we would have to have some sort of additional comment," Eshelman said.

Aside from that, PPD has simply said its December guidance for 2005 per-share earnings of $1.85 to $1.93 before items assumes its entire "discovery" business, which includes dapoxetine and other compounds under development, will cost earnings 17 to 21 cents a share.

A J&J spokeswoman declined to comment.

Under its agreement with Johnson & Johnson, PPD will receive double-digit royalties and as-yet unspecified payments pegged to sales if the drug is approved. The FDA goal date for completing a review of the new drug application, or NDA, filing is in October, and PPD is eligible for $20 million to $25 million in additional milestone payments from J&J before the drug is marketed.

But Coldwell and some other analysts who specifically track PPD have more conservative estimates than Merrill Lynch. They see enough uncertainty at the FDA in terms of leadership changes and increased scrutiny of so-called " lifestyle" drugs that they don't look for approval of dapoxetine until the middle of 2006 rather than the fourth quarter, as Merrill Lynch expects.

"For the time being, we've assumed it doesn't get approved right away," said Jefferies & Co. analyst David Windley.

He estimates sales of dapoxetine wouldn't hit $700 million until 2008, and he estimates the drug would cost $7 a pill, rather than the $10 a pill Merrill Lynch estimates.

If dapoxetine, in fact, has a Viagra-like launch, the impact could be " underappreciated" in the stock, Windley said. He also notes investors don't know exactly when royalty payments from Johnson & Johnson will kick in.

Under an amendment to their agreement last year, PPD agreed to give up royalties for an unspecified number of quarters in exchange for a prepayment. The payments could kick in earlier if sales top an unidentified amount.

"I'm not really showing a royalty stream ramping up for PPD really until 2007, " said Coldwell.

Regardless, he believes dapoxetine and PPD's other discovery business will be small contributors to profits for the next several years. "In 2010, I still have the entire discovery and internal (research and development) business contributing just 25 cents in earnings, and I have the company doing $4 (a share)," Coldwell said.

In addition, Windley notes, profits from dapoxetine would likely be plowed back into developing PPD's pipeline.

Still, if all goes well with dapoxetine, it would be a "big shot in the arm" to PPD's strategy of diversifying its business, he said.

Coldwell agrees. PPD's investments in discovering new compounds is a differentiating characteristic of the stock, he said.

Windley owns PPD shares, and Baird expects to seek or receive investment- banking-related compensation from the company in the next three months.

# posted by shyone72 @ 4:06 PM 0 comments

New "wonderdrug" treats premature ejaculation
Dapoxetine, a new drug meant to treat premature ejaculation in men, could make a bigger impact on the male sexual health market than Pfizer`s impotence blockbuster Viagra.

"Premature ejaculation is the most common male sexual dysfunction," said Dr. Jon Pryor, professor and chairman of the department of urologic surgery at the University of Minnesota`s Twin Cities Campus in Minneapolis. "About 20 percent of adult males have premature ejaculation at any one time, and 70 percent of men experience premature ejaculation at some time during their lives."

At the annual meeting of the American Urological Association in San Antonio, Pryor described clinical trials involving 2,614 men and their heterosexual partners who were willing to time their sexual activities with stopwatches in order to conduct the trial with the experimental drug. Dapoxetine is being developed by Ortho Urology, a division of Johnson & Johnson in New Brunswick, N.J.

Pryor said Ortho Urology had filed an application with the Food and Drug Administration for approval of dapoxetine for premature ejaculation. He added approval might occur within a year.

As soon as it receives FDA approval, the potential market for dapoxetine is huge, though doctors said how successful it will be in the marketplace depends on a number of factors.

"A lot will depend on how aggressively the company that makes dapoxetine will use direct-to-consumer advertising for premature ejaculation," said Dr. Jonathan Jarow, professor of urology at The Johns Hopkins University in Baltimore.

He noted that aggressive advertising for the erectile dysfunction drugs Viagra, Levitra and Cialis have created a major market -- yet the vast majority of the 30 million Americans with erectile dysfunction have not sought treatment. He said the same problems that make men reluctant to discuss and treat erectile dysfunction could impact sales of treatments for premature ejaculation.

Jarow said other drugs in the same class as dapoxetine are now prescribed by doctors for premature ejaculation and are recognized by the American Urological Association as treatments for the condition, but prescriptions of these medications -- called selective serotonin re-uptake inhibitors -- are for off-label use and therefore their manufacturers cannot advertise them for that purpose.

Pryor said study participants who took dapoxetine were able to increase their time to ejaculation significantly --from less than one minute to more than three minutes following vaginal penetration. He said normal time to ejaculation during sexual intercourse is about 7 to 9 minutes.

In addition to prolonging time to ejaculation, Pryor said, "Sexual satisfaction was improved by both the men and the partners who each filled out questionnaires regarding the experience with dapoxetine." He noted studies on sexual satisfaction often are performed only on one member of the partnership.

"The results with dapoxetine are compelling," Pryor said. "They demonstrate that, for the first time, a medicine can be taken by men on an on-demand basis and provide significant improvement in their premature ejaculation condition." He also said side effects from the drug were mild and infrequent.

Pryor reported on two identical studies in which premature ejaculating men were assigned either a placebo, a 30-milligram dose of dapoxetine or a 60-milligram dose of dapoxetine. The men took the pills about an hour before sexual activity and their partners were provided with stopwatches. The partners started the watches at the moment of vaginal penetration and stopped the timers upon ejaculation.

Before the trial, the study participants averaged 0.91 minutes before ejaculating during sexual intercourse. After 12 weeks of treatment, the 783 men on placebo averaged about 1.94 minutes before ejaculating, the 798 men on the 30-mg dose of dapoxetine ejaculated after an average of 3.02 minutes, and the 758 men on the 60-mg dose ejaculated after an average of 3.65 minutes. Researchers reviewed the patients` time scores every three weeks.

Pryor said perhaps even more important than the prolonged time to ejaculation were the scores of patients on tests of control of ejaculation and other factors related to satisfaction. Before the trial, he said, only 2 percent to 3 percent of the men said they felt control over ejaculation. After the trial about 25 percent of men on placebo said they controlled ejaculation, 50 percent of those on 30 mg of dapoxetine said they controlled ejaculation, 58 percent of those on 60 mg of dapoxetine said they controlled ejaculation.

At the start of the trial, about 21 percent of men on placebo said they were satisfied with their sexual relationship, after the trial 25 percent of those men said they were satisfied. About 21 percent of men taking the 60 mg dose of dapoxetine expressed satisfaction with their sexual lives before the trial started compared with 57 percent at the end of the trial.

At the start of the trial about 20 percent of the partners of the men on placebo were satisfied with their sexual relationship, and after the trial 25 percent of those women said they were satisfied. About 24 percent of the partners of men taking the 60 mg dose of dapoxetine expressed satisfaction with their sexual lives before the trial started compared with 58 percent of those women at the end of the trial.

When one considers that many couples would not participate in the trial when stopwatches ware mentioned, the couples in the trial had to have been highly motivated, suggested Dr. Gregory Broderick, professor of urology at the Mayo College of Medicine, Rochester, Minn.

"I think that means the participants in the study may have had the worse cases of premature ejaculation," Broderick said Monday. He moderated a press briefing that included the details on dapoxetine. "I would expect the numbers to be better if the drug is approved and is used by people without severe premature ejaculation."

# posted by shyone72 @ 4:06 PM 0 comments

Who wants to talk about Premature Ejaculation?
It is one of man’s most common, underestimated sexual problems: ejaculating earlier than desired. More common than erectile dysfunction, this condition can affect men at any point in their lives, and one in four men experience poor control over ejaculation on a frequent basis. According to published research, 20%–30% of men worldwide are commonly affected by premature ejaculation (PE), yet this medical condition remains a taboo subject in virtually every culture. Two presentations at this week’s 99th Annual Meeting of the American Urological Association (AUA) are helping to increase understanding and discussion of this common male sexual condition.

"Premature ejaculation is a frequent and distinct medical condition that can severely impact quality of life, affecting the physical and emotional well-being of patients and their partners," says James H. Barada, M.D., urologist at the Center for Male Sexual Health, Albany, NY, and board member of the Sexual Medicine Society of North America (SMSNA). "But most men are reluctant to talk about it with their partners or physicians."

To address whether renaming the condition would help increase awareness of, and discussion about, premature ejaculation, and reduce the stigma associated with it, the SMSNA has established a Scientific Working Group. The working group undertook a review of recent research and a representative research study, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. At the AUA, Dr. Barada presented the recommendations of the working group. The working group found that the term premature ejaculation was universally recognized and accurately understood by men with the condition and their partners, and concluded that changing the name may have the opposite effect, resulting in confusion and requiring extensive re-education. In the research study, which included 61 healthcare professionals, 75 men with premature ejaculation and 48 partners, other terms that also were occasionally used by physicians to describe the condition like "rapid ejaculation", were not as well understood by the study participants.

Most significantly, the results of the study highlight that the stigma is not associated with the name, but with the condition. The SMSNA Scientific Working Group recommends continued use of the term premature ejaculation to describe the condition, and in a move to minimize the stigma, calls on medical professionals to encourage communication about sexual health and the medical causes of premature ejaculation.

Why is premature ejaculation so stigmatized considering it is a well-known condition? Further research reported at the AUA by Andrew R. McCullough, M.D., Director of Male Sexual Health, Fertility and Microsurgery at the New York University Medical Center suggests that one of the reasons might be the broad impact that premature ejaculation has on many aspects of a man’s life, leaving him with feelings of embarrassment and inadequacy. Dr. McCullough’s analysis shows that men with poor control over ejaculation tend to be less satisfied with sexual intercourse and their sexual relationship, and may suffer more difficulties with sexual anxiety and arousal compared to non-sufferers (P <> 6 months) heterosexual relationships and answered 31 questions regarding overall and sexual health. These included questions about ejaculatory control that were primarily based on DSM-IV premature ejaculation criteria. According to these criteria, 32% of surveyed men identified themselves as sufferers, which is consistent with prevalence estimates in the literature. Of these, 189 men identified themselves as "probable" premature ejaculation sufferers, and a further 188 as "possible" sufferers.

Premature ejaculation is defined as persistent or recurrent ejaculation with minimal sexual stimulation before, upon, or shortly after penetration, or before the person wishes, causing distress and embarrassment to one or both partners, potentially affecting sexual relationships and overall well-being.

Johnson & Johnson Pharmaceutical Research & Development supported the SMSNA Scientific Working Group and the McCullough study.

ALZA Corporation obtained rights to develop and commercialize dapoxetine under an agreement among ALZA, Pharmaceutical Product Development, Inc. and its subsidiary, GenuPro, Inc. in January 2001. Under the agreement ALZA acquired the right to develop and commercialize dapoxetine for urogenital indications, including premature ejaculation, on a worldwide basis.

ALZA and Johnson & Johnson Pharmaceutical Research & Development, are developing dapoxetine and will seek approval from regulatory authorities around the world.

Dapoxetine is currently undergoing Phase III clinical evaluation. Following successful regulatory approval, dapoxetine will be marketed by Ortho-McNeil Pharmaceutical, Inc. in the USA, Janssen-Ortho Inc. in Canada and by Janssen-Cilag companies around the world.

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine: Drug for Premature Ejaculation
A new drug application for dapoxetine is currently under review by the U.S. Food and Drug Administration (FDA), and if approved, it will be the first prescription product indicated for the treatment of Premature Ejaculation. As said by Dr. Jon Pryor, professor and chairman of the department of urological surgery at the University of Minnesota's Cities campus in Minneapolis " Premature Ejaculation is the most common male sexual dysfunction and about 20 percent of adult males have premature ejaculation at any one time, and 70 percent of men experience premature ejaculation at some time during their lives." This new drug is meant to treat premature ejaculation and it’s estimated that it could make a bigger impact on the male sexual health market than Pfizer's impotence blockbuster Viagra. As compared to erectile dysfunction it has been estimated that PE may effect 27% to 34% of man across all age ranges, while ED is estimated to affect 10% to 12% of all men, who are usually older than age. Although PE is common it still remains widely under-diagnosed and under-treated. As soon as dapoxetine receives FDA approval, the potential market for it is huge, though doctors said that it depends on other factors. "Mainly a lot will depend on how aggressively the company will use direct to consumer advertising for PE" said Dr. Jonathan Jarow, Professor of Urology. He said that other drugs in the same class as dapoxetine are now prescribed by doctors for premature ejaculation and are recognized by the American Urological Association as treatments of the condition, but prescriptions of these medications- called selective serotonin- are for off label use and cannot be advertised. Researchers took 2614 men with PE and followed them for 12 weeks. The men were instructed to take a pill 1 to 3 hours before they planned to have sex. Though they didn't know it, some of the men were taking dapoxetine while others were taking a dummy pill, or placebo. Their partners–women–-held a stopwatch to time the period between penetration and orgasm. The men taking the placebo increased their time to ejaculation from about one minute to just less than two minutes, on average. The real drug, however, had a bigger effect. Men who took 30 mg. of dapoxetine held off their orgasm for nearly three minutes. Men on a 60 mg. dose did so for about three and a half minutes. A lot more men taking the drug rated their feelings of satisfaction as good or very good." The big increase was in sexual satisfaction rather being focused on time and only time." The percentage of men rating control over ejaculation as "fair to very good" increased dramatically for dapoxetine 30 mg (2.5% to 51.8%) and 60 mg (3.3% to 58.4%) compared to placebo (3.5% to 26.4%). The percentage of men rating sexual satisfaction as "good to very good" almost doubled with dapoxetine 30 mg (20.2% to 38.7%) and 60 mg (22.3% to 46.5%), respectively, in comparison to placebo (21.6% to 24.6%). The percentage of partners rating sexual satisfaction as "good to very good" almost doubled with dapoxetine 30 mg (20.4% to 39%) and 60 mg (24.8% to 47.4%), respectively, compared to placebo (20.1% to 25.2%). Dapoxetine can be taken as needed, just a few hours before a person plans to have sex, so it is relatively convenient. Other drugs-antidepressants-used to treat PE need to be taken continuously. Now one can comfortably get the pill from a general physician rather that going to a sex therapist. But there are some cautions as the drug isn't approved yet it is still waiting for FDA approval. The drug has side effects: 20 percent of men taking the higher dosage reported feeling nauseous. And many psychologists believe that the drug alone is not enough, it will work best paired with therapy to deal with feelings of inadequacy or anxiety that may contribute to PE. To read more visit http://www.med-review.com

# posted by shyone72 @ 4:06 PM 0 comments

Premature ejaculation is un-diagnosed and un-treated
According to a common estimate, premature ejaculation affects nearly 30% of men.

Almost all people who study premature ejaculation know that it is a heterogeneous population; probably one person with premature ejaculation is not the same as the next. So for some people it may be a psychological issue and for many others clearly there's a lot of evidence that it's biological.

Until now, there is no diagnostic criteria to say that this is what's causing it with you vs this is what's causing it with another patient. That gets back, to a certain extent, to lack of a understanding of the problem. To this day scientists still don't understand the entire process all that well, and because they don't understand it perfectly, they cannot have great diagnostic tests for it.

Despite the prevalence of this condition, it remains widely un-diagnosed and un-treated. On one hand, there is the lack of understanding the condition and the treatment options poorness that are available. On the other hand is the reluctance of the sufferers to come and ask for help.

People are embarrassed.
Men think, "Oh, I have this problem, but there's nothing for me, so therefore why voice a concern."
They think that it is a sign of weakness. Men don't want to be underperformers in bed and oftentimes that's how sufferers of premature ejaculation think of themselves, which is very sad. And so they accept to suffer in silence.

# posted by shyone72 @ 4:06 PM 0 comments

Study about Dapoxetine
Men taking dapoxetine hydrochloride for the treatment of premature ejaculation (PE) experienced significant improvements in sexual function, including ejaculatory control, satisfaction with sexual intercourse for both the men and their partners, and increases in intravaginal ejaculatory latency time (IELT), according to a new study.

The test involved 2,614 men aged between 18 and 77, who maintained monogamous sexual relationships of more than six months and suffered from premature ejaculation.

Each received 30 milligrams or 60 milligrams of dapoxetine over 12 weeks in two identical placebo-controlled trials.

The results showed the drug helped them lengthen intercourse three to four times. What's more, dapoxetine increased their staying power with the first dose and helped maintain the increases over the whole study period.

The percentage of study participants rating their control over ejaculation as "fair to very good" increased from 2.5 percent to nearly 52 percent for those taking 30-milligram doses of dapoxetine. For those taking 60 milligrams, it shot up from 3.3 percent to more than 58 percent, the trials showed.

The share of pill takers calling their satisfaction from intercourse "good to very good" almost doubled, as did the satisfaction of their female partners.

The most common adverse side effect reported with both doses were nausea and headache.

Doctor Jon Pryor, chief urologist at the University of Minnesota and lead researcher said: "They demonstrate that, for the first time, a medicine can be taken by men on an on-demand basis and provide significant improvement in their PE condition."

# posted by shyone72 @ 4:06 PM 0 comments

Johnson & Johnson "Market Perform"
NEW YORK, May 30 (newratings.com) - Analyst Michael Krensavage of Raymond James maintains his "market perform" rating on Johnson & Johnson (JNJ.NYS).

In a research note published on May 27, the analyst mentions that the company is expected to either seek the approval for or launch thirteen new molecular entities, which includes HIV and cancer drugs and the dapoxetine drug for premature ejaculation, by 2007. Till now, Johnson & Johnson has not been able to receive approval for any of its internally developed new molecular entities, the analyst says. Raymond James expresses its concern regarding the growth prospects of dapoxetine, since it might cause sexual dysfunction and is likely to be met with stiff competition from generic Prozac.

# posted by shyone72 @ 4:06 PM 0 comments

Causes of Premature Ejaculation problems
What exactly causes Premature Ejaculation problems in so many men? Well, there are a number of potential causes.

- Stress & anxiety
Stress and anxiety, if you are experiencing any in your life, could be affecting your love life as well. So, trying to relax as much as possible before lovemaking, it will help you.

A special category of anxiety is related to first sexual experience. Some time, the anxiety of that first sexual experience is too intense and the pressure to perform – and the desire to “get it right” can result in premature ejaculation. And once it happened once, next time there is the fear it may happen again, which again breads anxiety. And so a vicious cycle is born.

Many men get over this naturally, and proceed to have normal functions. But for many of us – particularly if you have that type of personality that dwells on things – this fear is self-perpetuating into adulthood.

- Tiredness & depression
In some situations, tiredness or clinical depression may play an important role. If you find yourself to be constantly tired, you should take a look at your general lifestyle and physical health to help improve the situation. If you suspect depression, again, you should seek medical assistance.

- Relationship issues
Relationship issues can be stressful, and we’ve already seen how stress can get in the way of good sex. Take care to a relationship based only on sexual satisfaction. Some partners claim to be all perfect all the time, and this type of behavior may induce a sort of anxiety.

- Health issues
Being “run down” or “under the weather” can be a contributing factor to Premature Ejaculation. However, these should only be short term – unless the original experiences have produced stress and anxiety about your lovemaking that continues long after the original cause.

- Medical Reasons
Prostrate problems and infections such as urethritis are believed to cause Premature Ejaculation. Fortunately, these are in a very small minority of cases, and are treatable with medical assistance.

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine - In the news
Here's a little article on Dapoxetine and how it works.
http://www.dancewithshadows.com/business/premature-ejaculation-drug.asp

# posted by shyone72 @ 4:06 PM 0 comments

Background of premature ejaculation
Premature ejaculation (PE) is the most common sexual dysfunction complaint in men younger than 40 years. Most professionals who treat PE define this condition as the occurrence of ejaculation prior to the wishes of both sexual partners. This broad definition thus avoids specifying a precise duration for sexual relations and reaching a climax, which is quite variable and depends on many factors specific to the individuals engaging in intimate relations. An occasional instance of PE might not be cause for concern, but if the problem occurs with more than 50% of attempted sexual relations, then a dysfunctional pattern usually exists for which treatment may be appropriate.

What is Premature Ejaculation?

Premature Ejaculation is one of the most common forms of male sexual problems which have affected almost every man at some point in life.

Premature Ejaculation is the inability to delay ejaculation to a point which is mutually desirable for both partners. Usually it leads to an unsatisfactory sexual experience for both the partners.

The duration of time for ejaculation is not the true concern during the intercourse but the issue is whether the couple is really satisfied with the activity or not.

What causes it?

Though it is quite common in men, the exact cause of Premature Ejaculation is still unclear. Experience and Psychological factors have been primarily related as contributors to this condition.

Premature Ejaculation often occurs during the first experience with sex and the lack of ejaculatory control combined with anxiety is responsible towards it.

However, psychological factors such as guilt, depression, anxiety, insomnia etc. also result in this situation. Other factors such as stopping alcohol consumption before sex and a long time gap since the last ejaculation equally relate to the condition.

Is there any Solution?

It has been found that premature ejaculation resolves on its own over time without the need for a medical treatment. However, practicing relaxation techniques or using distraction methods can also help you in delaying ejaculation. You may practice techniques like Masters and Johnson Method, Simulation Technique or Squeeze Technique to exercise greater control over your performance. In addition, keeping a check over the alcohol intake and illegal drug usage is also helpful.

# posted by shyone72 @ 4:06 PM 0 comments

More sex with Dapoxetine?
Medical Science is making fast strides.

Many drugs are hitting the market, thanks to Medical Research!

Men seem to have more Sexual Problems like their wife (lady)-generated family problems!

It is estimated that just 10 to 12 percent of all men (mostly old ones) suffer from Erectile Dysfunction (impotence). Viagara & similar drugs are there to cure this dysfunction to a level.

But a whopping 27 to 34 percent of men of all age groups are estimated to suffer from Premature Ejaculation (doesn't the sound of this word echoe the sense?) -P.E. as it is fondly called & there is no known therapies for this condition.

Thanks to Medical Research, now a new wonder drug called DAPOXETINE has been introduced in the U.S. of America & it is reported to increase intercourse (Staying power) three to four times.

Isn't it a boon to many men & incidentally to all ladies?

What's your take on this Sexathon? Throw caution to the winds & Blurt out! :)

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine and Male Sexual Health
Sexuality is the fundamental part of every human being's personality. Its complete development rests on the satisfaction of basic human needs like desire for love, intimacy, emotional expression and pleasure. The environment which recognizes, accepts and exercises sexual rights such as rights to sexual freedom, autonomy, privacy, pleasure or expression upholds sexual health. For sexual health to be attained and maintained, the sexual rights of all people must be respected, protected and fulfilled.

The World Health Organization (WHO) defines sexual health as "the state of physical, emotional, mental and social well-being related to sexuality; it is not merely the absence of disease, dysfunction or infirmity. Sexual health requires a positive, respectful approach to sexuality and sexual relationships, as well as the possibility of having pleasurable and safe sexual experiences, free of coercion, discrimination and violence.

The common issues that cover male sexual health segment can be listed as below.

* Masturbation
* Erectile Dysfunction Issues
* Prostate Health
* Rapid or Delayed Ejaculation
* Ejaculate Issues
* Penis and Testicular Health
* Infertility Medications and Supplements
* Contraception

# posted by shyone72 @ 4:06 PM 0 comments

Dapoxetine: A new drug to treat premature ejaculation
What is Premature Ejaculation?
Premature Ejaculation is one of the most common forms of male sexual problems which have affected almost every man at some point in life. The duration of time for ejaculation is not the true concern during the intercourse but the issue is whether the couple is really satisfied with the activity or not.

An occasional instance of PE might not be cause for concern, but if the problem occurs with more than 50% of attempted sexual relations, then a dysfunctional pattern usually exists for which treatment may be appropriate.

What causes it?
Though it is quite common in men, the exact cause of Premature Ejaculation is still unclear. Experience and Psychological factors have been primarily related as contributors to this condition. The duration of time for ejaculation is not the true concern during the intercourse but the issue is whether the couple is really satisfied with the activity or not.

However, psychological factors such as guilt, depression, anxiety, insomnia etc. also result in this situation. Other factors such as stopping alcohol consumption before sex and a long time gap since the last ejaculation equally relate to the condition.

If PE relates to ED, then it may resolve if ED is treated successfully. Drugs for the treatment of ED include Viagra and Cialis. ALZA and Johnson & Johnson Pharmaceutical Research & Development, are developing dapoxetine for premature ejaculation problem and will seek approval from regulatory authorities around the world.

# posted by shyone72 @ 4:06 PM 0 comments
Saturday, June 04, 2005

Finally, help for premature ejaculation!
Looks like there may finally be help for premature ejaculation. It's called Dapoxetine and it's being developed by Johnson & Johnson. I just heard about it and am finding out the details. Will publish them here when I find out more!

# posted by shyone72 @ 11:34 AM 0 comments

cureprematureejaculation