Pharmacokinetic and pharmacodynamic features of dapoxetine, a novel drug for ‘on‐demand’ treatment of premature ejaculation

Associate Editor Michael G. Wyllie Editorial Board Ian Eardley, UK Jean Fourcroy, USA Sidney Glina, Brazil Julia Heiman, USA Chris McMahon, Australia Bob Millar, UK Alvaro Morales, Canada Michael Perelman, USA Marcel Waldinger, Netherlands OBJECTIVE To describe the relationship between the pharmacokinetic and pharmacodynamic properties of dapoxetine, a drug specifically developed for treating premature ejaculation (PE). METHODS Data from various stages of the clinical development programme were analysed using validated methods for assessing ejaculatory latency. The clinical characteristics were then compared with the pharmacokinetic profile, determined from measured plasma drug concentrations. RESULTS Pharmacodynamic and pharmacokinetic measurements confirm that ‘on demand’ dapoxetine has a rapid onset of action and is rapidly cleared after sexual intercourse. CONCLUSION Dapoxetine may represent the first of a new category of selective serotonin transport inhibitors. Although dapoxetine has pharmacological similarities to other selective serotonin transport inhibitors, its efficacy after acute administration sets it apart and suggests a different mode of action. Its physicochemical and pharmacokinetic properties and its clinical efficacy make dapoxetine suitable for on‐demand treatment of PE.