Drug to treat premature ejaculation in men, PSD502, shows promising results

PSD502 is shown to be able to delay ejaculation up to six times longer.

Sciele Pharma, Inc a Shiongi Company, and Plethora Solutions Holdings PLC presented highly encouraging results from a European phase-III randomized, double-blind, placebo-controlled study of PSD502 for the treatment of premature ejaculation (PE).

PSD502, a drug developed by Sciele Pharma and Plethora Solutions, has been found highly effective to treat premature ejaculation in men.

Studies using PSD502 has found that men treated with PSD502 five minutes before intercourse were able to delay ejaculation up to six times longer than those who used a placebo.

PSD502 has also significantly improved overall sexual satisfaction scores in patients and their partners.

PSD502 is a formulation of lidocaine and prilocaine. The PSD502 study conducted in Europe is one of the two major international trials. PSD502 study was designed to determine whether PSD502, a metered-dose aerosol formulation of lidocaine and prilocaine, would result in longer intravaginal ejaculatory latency time (IELT) in men who suffer from premature ejaculation. The study also assessed the safety and tolerability of the therapy.

Lidocaine is a common drug used in local anesthesia and antiarrhythmia. Lidocaine  is also often combined with lidocaine as a preparation for dermal anesthesia, for treatment of conditions like paresthesia. Lidocaine has low cardiac toxicity, it is commonly used for intravenous regional anaesthesia.

“The data suggest that PSD502 is effective in delaying ejaculation for several minutes, significantly improving the overall sexual experience. Equally important is the fact that in this trial PSD502 was shown to be well tolerated and well accepted by patients,”said professor Wallace Dinsmore, Royal Victoria Hospital, Belfast, UK, and lead study investigator.

“Premature ejaculation is a very distressing condition that can have a devastating impact on the intimate relationship between men and their partners,” he added.

Premature ejaculation is experienced by up to 30 percent of the adult male population at some time in their lives, yet there is no FDA-approved prescription product to treat this sexual dysfunction, said Ira D Sharlip, clinical professor of urology, University of California, San Francisco.

The aerosol formulation of lidocaine and prilocaine is an easy-to-use topical spray. It selectively desensitizes penile skin, affecting only the inner lining of the foreskin and the surface of the glans, without adversely affecting the sensation of ejaculation. This new treatment can be applied five minutes prior to intercourse.

“The significant improvement in ejaculatory control and overall sexual satisfaction reported by men using PSD502 in this study is very encouraging news for physicians who treat these patients. PSD502 may represent a promising new therapy in the management of premature ejaculation, meeting an unmet medical need in a condition that affects millions of men,” said Ed Schutter, president and chief operating officer of Sciele Pharma. “We look forward to completing the North American phase-III study in the second half of this year, with an anticipated filing with the FDA in the first half of 2010.”

There is no effective therapy for premature ejaculation.One current treatment for premature ejaculation consists of topical creams with desensitizing agents which dull the penile skin and delay ejaculation. These creams require use of a condom and/or washing the cream away before intercourse and they may reduce sexual pleasure.

Sciele Pharma, a Shionogi Company, is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on the therapeutic areas of cardiovascular, diabetes, women’s health and paediatrics.

Plethora is focused on the development and marketing of products for the treatment of urological disorders.

Shionogi is a major research-driven Japanese pharmaceutical manufacturer.