Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Plethora Solutions Holdings has completed the recruitment into the final part of the PSD502 registration program for the treatment of premature ejaculation.
Subscribe to our email newsletter
Recruitment to the final arm of the global Phase III program has now closed. All patients have entered a four-week screening and baseline period, with at least 240 patients expected to be randomized shortly to a 12-week double-blind treatment period followed by an optional open-label phase.
The primary endpoints, as in the European study, are intra-vaginal ejaculation latency time, sexual satisfaction and ejaculatory control. Secondary endpoints include sexual quality of life and partner satisfaction. The results from this North American study are expected in mid-2009.
Two pivotal studies have now been conducted 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. The conclusion of the North American program represents the culmination of the global Phase III program for PSD502.
Mike Wyllie, chief scientific officer of Plethora, said: This represents a major milestone in the clinical development program of PSD502 and we expect to report on the outcome later in 2009. At that time, filings for global product registration are expected to be completed.