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). In this study, men treated with PSD502 five minutes before intercourse were able to delay ejaculation up to six times longer than those who used a placebo. Additionally, patients and their partners reported significant improvements in overall sexual satisfaction scores when using PSD502. The results were presented at the American Urological Association Annual Meeting.
"Premature ejaculation is a very distressing condition that can have a devastating impact on the intimate relationship between men and their partners," said professor Wallace Dinsmore, Royal Victoria Hospital, Belfast, UK, and lead study investigator. "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. "
The European phase-III study, one of two major international trials, 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 PE. The study also assessed the safety and tolerability of the therapy.
"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 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."
PSD502 is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol developed for the treatment of premature ejaculation, a disorder reported to affect between 25 and 30 per cent of men in Europe and the USA.
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.