Plethora completes European Phase III premature ejaculation trial

The study was initiated in December 2007 and these results from the blinded study are expected in the fourth quarter of 2008. There are two pivotal PSD502 studies running in parallel, one in North America and one in Europe. Each is a multi-center, randomized, double blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. Approximately 275 patients will have completed the blinded phase of the study across 32 investigational centers in four countries across Europe. Of these, 265 patients have entered an optional five-month open-label study.

Recruitment in the equivalent study in the US is ongoing and data from the two studies will be combined for submission for regulatory approval in the US and Europe. A new drug application 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 US.

Mike Wyllie, chief scientific officer of Plethora, said: “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 premature ejaculation patients in the general population and their willingness to seek treatment.”