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. 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.
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