Dapoxetine

Abstract

Dapoxetine, a selective serotonin reuptake inhibitor, is the first oral pharmacological agent indicated for the treatment of men aged 18-64 years with premature ejaculation. In four randomized, double-blind, placebo-controlled, multicentre studies of 12-24 weeks' duration, oral dapoxetine 30 or 60 mg (administered as needed) was effective in the treatment of men with premature ejaculation, inducing significantly (p < 0.001) greater improvements from baseline than placebo in the primary efficacy endpoint (mean intravaginal ejaculatory latency time [IELT] or mean average IELT [defined as the average of IELT values over the previous 4 weeks], as measured by the female partner utilizing a stopwatch). For the most part, dapoxetine recipients achieved significantly better outcomes than placebo recipients with regard to the secondary endpoints, including the Premature Ejaculation Profile (PEP) domains and the Clinical Global Impression or Patient Global Impression ratings of change in premature ejaculation, across these clinical studies. The beneficial effects of dapoxetine therapy on the perceived control over ejaculation and satisfaction with sexual intercourse PEP domains were sustained in a 9-month noncomparative extension phase of two identical 12-week, double-blind studies. Oral dapoxetine therapy for up to 12 months was generally well tolerated in men with premature ejaculation, with the nature of treatment-emergent adverse events generally similar across the clinical studies and between dapoxetine and placebo.