Data presented today demonstrates that 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 men and their partners, and increases in intravaginal ejaculatory latency time (IELT)*. The U.S. Food and Drug Administration is currently reviewing a New Drug Application for dapoxetine, which if approved, would be the first prescription product indicated for the treatment of PE. These data were presented at the 100th Annual Scientific Meeting of the American Urological Association.

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. PE can be a lifelong condition experienced from the beginning of sexual activity or can develop after years of satisfactory sexual activity.

"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," says Jon L. Pryor, M.D., chairman and program director of the Department of Urologic Surgery at the University of Minnesota and lead investigator of the dapoxetine phase III clinical trials. "The results with dapoxetine are 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. The unique profile of dapoxetine translated into targeted treatment of PE compared to existing therapies. There are meaningful improvements in this study across all primary and secondary endpoints, including a three-to-four fold increase in IELT."

Phase III Trial Design and Results

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

About Premature Ejaculation (PE)

Although PE is one of the most common male sexual disorders, it remains widely under-diagnosed and under-treated. Most physicians do not screen for PE and patients are extremely reluctant to talk about the condition with their partners or health care professionals. 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.

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. The study found that men with PE and their partners reported higher ratings for interpersonal difficulty, lack of control over ejaculation and dissatisfaction with sexual intercourse.

About Ortho Urology

Ortho Urology, a unit of Ortho-McNeil Pharmaceutical, Inc., has a proven track record of leadership in the field of urology and is committed to providing patients with products that help them live healthier lives and improve their quality of life. Ortho Urology has a history of clinical expertise and is committed to bringing patients the most advanced options in urology with products such as ELMIRON® (pentosan polysulfate sodium) and DITROPAN XL® (oxybutynin chloride).

* Intravaginal Ejaculatory Latency Time (IELT) – IELT was first introduced in 1994. It is used in clinical setting involving the study of premature ejaculation. A stopwatch may be operated by either partner and is activated when the male enters the female and stopped when a man ejaculates. The amount of time this process takes is known as intravaginal ejaculatory latency time or IELT.

** Represents Hispanic, Caucasian and African American men.