Plethora Solutions completes European trial of PSD502 for premature ejaculation

Sciele Pharma, Inc. today announced that Plethora Solutions Holdings PLC has completed its European Phase III study of PSD502 for the treatment of premature ejaculation (PE) in Europe. The study was initiated in December 2007 and these results from the blinded study are expected in the fourth quarter of 2008.

In recently published results from a Phase II study, PSD502 was shown to increase ejaculation latency time significantly when compared with placebo (Dinsmore W et al BJU Int 2007; 99: 369-35).

There are two pivotal PSD502 studies running in parallel, one in North America and one in Europe. Each is a multi-centre, randomized, double blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. 275 patients will have completed the blinded phase of the study across 32 investigational centers in 4 countries across Europe. Of these, 265 patients have entered an optional 5 month open-label study.

Recruitment in the equivalent study in the U.S. is ongoing and data from the two studies will be combined for submission for regulatory approval in the U.S. and Europe. A new drug application (NDA) for PSD502 is expected to be submitted to the FDA in the first half of 2009.

In May 2007, Sciele signed an exclusive licensing agreement with Plethora Solutions to market PSD502 in the U.S.

Larry Dillaha, M.D., Chief Medical Officer of Sciele Pharma, said, "We are pleased with the progress Plethora has made with the development of PSD502, which addresses an unmet medical need that affects a significant number of adult males in all age groups."

Dr. Mike Wyllie, CSO of Plethora, commented, "We are delighted to have completed this arm of the Phase III study. The willingness of patients to enter the open-label study is most encouraging as is the low dropout rate throughout the trial. The speed at which recruitment was completed, given the stringent entry criteria, confirms both the number of PE patients in the general population and their willingness to seek treatment."