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Pivotal study for PSD502 -- the first potential treatment for premature ejaculation
Date:11/19/2009

ATLANTA / SAN DIEGO (November 19, 2009) At the annual meeting of the Sexual Medicine Society of North America (SMSNA), Inc. in San Diego, Sciele Pharma, Inc., a Shionogi Company and Plethora Solutions Limited, a wholly owned subsidiary of Plethora Solutions Holdings PLC ("Plethora" AIM:PLE)., today presented data from its second positive pivotal study of PSD502 for the treatment of premature ejaculation (PE). Results of the double-blind treatment phase of this study, which enrolled patients from the U.S., Canada and Poland, are consistent with previously reported results of the pivotal trial conducted in Europe and showed that men who were treated with PSD502 five minutes before intercourse were able to delay ejaculation up to five times longer than those who used placebo. Additionally, patients and partners in both trials reported significant improvements in sexual satisfaction, and the drug was well tolerated.

An estimated one-third of U.S. men ages 18 - 59 are affected by PE, making it twice as prevalent as erectile dysfunction. Currently, there are no prescription therapies approved in the U.S. to treat PE.

PSD502, a product in development for the treatment of PE, is a proprietary formulation of the two marketed drugs lidocaine and prilocaine dispensed by a metered dose aerosol. PSD502 works selectively on non-keratinized skin on the glans penis (head of the penis).

"Premature ejaculation can have a powerful negative impact on the emotional and sexual lives of men and their partners," said Professor Stanley E. Althof, PhD, Center for Marital and Sexual Health of South Florida, West Palm Beach, Florida. "Recently, the international sexual health community agreed that PE should be defined as ejaculation occurring within approximately one minute of penetration that causes the patient distress. Now we need to work to develop treatments, and these encouraging results with PSD502 seem to be a step in the right direction."


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Contact: Dave Schemelia
dschemelia@healthstarpr.com
609-468-9325
HealthStar PR
Source:Eurekalert

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