The Pharmaceutical Journal
Vol 277 No 7418 p331
16 September 2006

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On-demand SSRI for premature ejaculation proves effective

A selective serotonin reuptake inhibitor developed specifically for on-demand treatment of premature ejaculation has shown promising results in phase III trials.

SSRIs are increasingly being used as off-label treatment for premature ejaculation as a result of their side effect of delayed ejaculation. However, SSRIs licensed to treat depression are long-acting and associated with a number of adverse effects. Dapoxetine, a short-acting SSRI that takes one hour to reach maximum serum concentration and has a half-life of 1.2 hours, was therefore developed to treat premature ejaculation.

Researchers combined the results of two randomised controlled trials involving over 2,600 men with moderate to severe premature ejaculation. The men were given either placebo, dapoxetine 30mg or dapoxetine 60mg as needed, one to three hours before anticipated intercourse. The primary endpoint was intravaginal ejaculatory latency time (IELT).

The results showed that dapoxetine prolonged IELT compared with placebo (P<0.0001). At baseline, mean (standard deviation) IELT was 0.90 (0.47), 0.92 (0.50) and 0.91 (0.48) minutes in the placebo, dapoxetine 30mg and dapoxetine 60mg groups, respectively. At week 12, it was 1.75 (2.21), 2.78 (3.48) and 3.32 (3.68) minutes, respectively. Both doses of dapoxetine were effective from the first dose, say the researchers.

Dapoxetine also resulted in improvements in patient perception of control over ejaculation, satisfaction with sexual intercourse and overall impression of change in condition. Partners benefited through improved satisfaction with sexual intercourse, they add.

The most common adverse effects were nausea, diarrhoea, headache and dizziness, and were dose-related, say the researchers. Sexual side effects were reported in 2.9 per cent of those on dapoxetine 30mg and 3.8 per cent of those on dapoxetine 60mg.

“These trials have shown that dapoxetine is effective and generally well tolerated for the treatment of premature ejaculation when given on demand,” the researchers conclude (Lancet 2006;368:929).