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