Sciele Pharma And Plethora Solutions Announce That PSD502 Demonstrates Substantial Benefit In The Treatment Of Premature Ejaculation

Sciele Pharma, Inc. a Shiongi Company, and Plethora Solutions Holdings PLC ("Plethora" - AME:PLE) today 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 today 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, M.D., 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."


European Phase III Study


The European study was conducted with 300 randomized patients across 32 investigational centers in four countries across Europe. Of these, 268 patients have now been entered into the optional nine-month open-label study.


Final analyses confirmed that PSD502 produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints, and also in all secondary endpoints. The IELT for PSD502 was four minutes compared with one minute in placebo (p

Of patients who received PSD502, 91% achieved an IELT of greater than one minute and 75% achieved an IELT of greater than two minutes following treatment. This compared with only 54% and 22% of placebo patients, respectively. Both endpoints were highly clinically and statistically significant (p

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