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.
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Sciele Pharma Inc., a Shionogi Company, and Plethora Solutions Holdings PLC (”Plethora” – AIM:PLE), announced that a second and final Phase III double-blind, placebo-controlled study of PSD502 for the treatment of premature ejaculation (’PE’) has met all co-primary endpoints of Intra-vaginal Ejaculation Latency Time (’IELT’), Index of Premature Ejaculation (’IPE,’ Ejaculatory Control, Sexual Satisfaction and Distress domains).

This successful study, involving patients from the USA, Canada and Europe, is one of two pivotal Phase III studies that were run in parallel with identical protocols. The previously announced Phase III study was conducted entirely in Europe, and its successful outcome was reported in November 2008. Data from the two studies will be combined for submission for regulatory approval in the USA and Europe.
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