Dapoxetine for premature ejaculation.

BACKGROUND

Premature ejaculation (PE) is a common male sexual disorder which is associated with substantial personal and interpersonal negative psychological factors. Drug treatment of PE with an off-label antidepressant selective serotonin reuptake inhibitor (SSRI) drug is common. The lack of an approved drug and total reliance on off-label treatment represents a substantial unmet treatment need.

METHODS

Medline and the proceedings of major international and regional scientific meetings during the period 1994-2010 were searched for publications or abstracts using the word 'dapoxetine' in the title, abstract or keywords. This search was then manually cross-referenced for all papers. This review encompasses studies of dapoxetine pharmacokinetics, animal studies, human phase I, II and III efficacy and safety studies and drug-interaction studies. Dapoxetine is a potent SSRI, which is administered on demand 1-3 h before planned sexual contact. Dapoxetine is rapidly absorbed and eliminated, resulting in minimal accumulation and has dose-proportional pharmacokinetics, which are unaffected by multiple dosing. Dapoxetine 30 and 60 mg has been evaluated in five randomized, double-blind, placebo-controlled studies in 6,081 men aged > or = 18 years. Outcome measures included stopwatch-measured intravaginal ejaculatory latency time (IELT), Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events. Mean IELT, all PEP items and CGIC improved significantly with both doses of dapoxetine versus placebo (p < 0.001 for all). The most common adverse events included nausea, dizziness and headache, and evaluation of validated rated scales demonstrated no SSRI class-related effects with dapoxetine use.

RESULTS

Readers will gain insight into the epidemiology, pathophysiology and contemporary drug treatment of premature ejaculation.

CONCLUSIONS

Dapoxetine, as the first drug developed for PE, is an effective and safe treatment for PE and represents a major advance in sexual medicine.