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Pivotal Data for the Investigational Treatment PSD502 for Primary Premature Ejaculation in the United States to be Presented at Major Medical Meeting
Date:6/1/2010

SAN FRANCISCO and ATLANTA, June 1 /PRNewswire/ -- Shionogi Pharma, Inc., a U.S.-based group company of Shionogi & Co., Ltd., today presented data summarizing the results of two pivotal studies of the investigational new drug PSD502, a topical metered dose spray, being developed for the treatment of primary premature ejaculation (PE).  These data were presented at the 2010 American Urological Association (AUA) Annual Meeting in San Francisco.

Evaluating a combined total of 556 (randomized) and 536 (treated) men with primary PE in the United States, Canada and Europe over a three-month period, with more than 23,000 exposures to PSD502 recorded, the data demonstrated that men who were treated with PSD502 five minutes before intercourse by applying PSD502 to the glans penis via a topical metered dose spray had a time to ejaculation (measured in minutes) 5.5 times longer than those who used a placebo spray.

A co-primary endpoint also looked at ejaculatory control and satisfaction. Point differences of 6.0 and 5.3 were observed between the PSD502 group and placebo in ejaculatory control and satisfaction domains, respectively (p<0.0001 for all).

"Combined results from the PSD502 pivotal studies are very exciting and this is a significant milestone for men suffering from PE," said Ira D. Sharlip, MD, clinical trial investigator and clinical professor of urology at the University of California, San Francisco.  

The exact incidence of PE is not known, as a widely accepted definition of PE has only recently become available. Depending o
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SOURCE Shionogi Pharma, Inc.
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