Washington, June 1 (ANI): An investigational new drug PSD502 has been found highly effective in treating primary premature ejaculation (PE).
Shionogi Pharma, Inc., a U.S.-based group company of Shionogi and Co., Ltd., has presented data summarizing the results of two pivotal studies of PSD502, a topical metered dose spray being developed for the treatment of PE.
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 via a topical metered dose spray had a time to ejaculation 5.5 times longer than those who used a placebo spray with the actual average measurement in minutes for drug and placebo.
A co-primary endpoint also looked at ejaculatory control and satisfaction. Point differences of 6.1 and 5.3 were observed between the PSD502 group and placebo in ejaculatory control and satisfaction domains, respectively.
"Combined results from the PSD502 pivotal studies are very exciting and this is a significant milestone," said Ira D. Sharlip, clinical trial investigator and clinical professor of urology at the University of California, San Francisco.
These data were presented at the 2010 American Urological Association (AUA) Annual Meeting in San Francisco. (ANI)