Current and future pharmacotherapies of premature ejaculation

Abstract

Introduction: There are currently no oral or topical agents approved by government regulation agencies for the management of premature ejaculation (PE).

Aim: To review pharmacologic therapies for treatment of PE.

Methods: The Sexual Medicine Society of North America hosted a State of the Art Conference on Premature Ejaculation on June 24-26, 2005 in collaboration with the University of South Florida. The purpose was to have an open exchange of contemporary research and clinical information on PE.

Main outcome measure: Data were obtained by extensive examination of peer-reviewed published literature.

Results: Chronic administration of selective serotonin reuptake inhibitors (SSRIs) is associated with an increased adverse event profile encompassing dry mouth, nausea, drowsiness, and reduced libido. Their use may also facilitate the development of other sexual dysfunctions, such as anejaculation and erectile dysfunction (ED). Phosphodiesterase-5 (PDE-5) inhibitors have also been investigated for the management of PE, as an indirect consequence of their ability to prolong erections. Trials have found PDE-5 inhibitors to be appropriate for men with PE secondary to ED, or when they are used in conjunction with other agents such as SSRIs. Trials of topical formulations that contain either anesthetic agents or other ingredients report significant increases in ejaculatory latency times; however, long-term safety and efficacy studies are lacking. New agents are being developed specifically for the management of PE. Among these are a topical formulation and numerous oral agents. Only one agent--dapoxetine hydrochloride (DPX)--has undergone Phase III trials. DPX is a serotonin transport inhibitor (STI) with a pharmacokinetic profile conducive to on-demand dosing for the management of PE. Unlike the current oral agents, DPX has a rapid onset of action and is effective from the first dose.

Conclusions: Well-designed clinical trials utilizing appropriate outcome measurements are needed to provide safe and effective pharmacologic options for men with PE.