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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Premature ejaculation can be embarrassing, but a new study suggests that it might be a genetic disorder.

Researchers from Turku, Finland, interviewed more than three thousand men – all pairs of male twins and their older or younger brothers – about the first time they had sex. Many participants in the study reported that they had suffered from erectile dysfunction and premature ejaculation at their first sexual encounter. These common problems are often attributed to external factors, such as intoxication or nervousness due to peer pressure. This research confirms that such factors do cause erectile dysfunction. On the other hand, premature ejaculation appears to be strongly linked to genetic factors, and is not just psychological.
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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.
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Men with premature ejaculation who used a topical spray five minutes before intercourse were able to delay their orgasm six times longer than normal, according to a study in the April issue of BJU International.

Three hundred men with clinically diagnosed lifelong premature ejaculation (PE) from 31 centres in the UK, Czech Republic, Hungary and Poland, were randomised into two groups. Two hundred used the PSD502 spray, which contains 7.5mg of lidocaine and 2.5mg of prilocaine, and 100 used a placebo spray with no active ingredients.
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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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