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| |  Dapoxetine Hydrochloride Significantly Improves Premature Ejaculation By Jill Stein 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.
[Presentation title: Efficacy and Tolerability of Dapoxetine in the Treatment of Premature Ejaculation. Abstract 740]
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