Dapoxetine for premature ejaculation
Abstract
IMPORTANCE OF THE FIELD: 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.
AREAS COVERED IN THIS REVIEW: 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.…
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