Dapoxetine: a novel treatment for premature ejaculation.

Premature ejaculation (PE) is a common problem worldwide and has significant impact not only on the sufferer but on the partner in terms of self-esteem, interpersonal distress and sexual satisfaction. A variety of psychological, topical and oral therapies have been tried in this condition with varying degrees of success. The selective serotonin reuptake inhibitors (SSRIs) are known to cause delayed ejaculation but require daily administration, have a relatively slow onset of action and may cause SSRI discontinuation syndrome on withdrawal. In addition, they are currently unlicensed for PE. Dapoxetine hydrochloride, an SSRI, has been specifically developed for on-demand use in PE. Its pharmacokinetic profile is characterized by rapid absorption, a short initial half-life of 1.3-1.4 h and rapid elimination with minimal accumulation even after multiple dosing. Several large phase III studies have demonstrated that dapoxetine can increase intravaginal ejaculatory latency time and improve several patient-reported outcomes relevant to control of ejaculation and satisfaction with intercourse. Dapoxetine is generally well tolerated with a low incidence of discontinuations due to adverse events. There were no signals for treatment-emergent anxiety or SSRI discontinuation syndrome after abrupt withdrawal.