Sciele Pharma, Inc., a Shionogi company, and Plethora Solutions Holdings PLC announced the completion of patient recruitment of the PSD502 registration programme for the treatment of premature ejaculation (PE).
The preliminary results from this North American study are expected in midyear 2009. A parallel European phase III study of PSD502 concluded successfully in November 2008 with a positive outcome that was both clinically and statistically significant.
Each of these two pivotal studies is a multi-centre, randomized, double-blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. The conclusion of the North American programme represents the culmination of the global phase III programme for PSD502.
North American Study Details: Recruitment of the global phase III programme 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 (IELT), sexual satisfaction and ejaculatory control. Secondary endpoints include sexual quality of life and partner satisfaction.
European phase III study outcome: Data from the European phase III reported in November 2008 showed that PSD502 produced both clinically and statistically significant increases from baseline in all three co-primary study endpoints and secondary endpoints. There were no serious adverse events, the drug was well tolerated and there were no systemic adverse events.
Dr. Mike Wyllie, CSO of Plethora, commented, "This represents a major milestone in the clinical development programme of PSD502, and we expect to report on the outcome later in the year. At that time, filings for global product registration are expected to be completed."
PSD502 is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol developed for the treatment of premature ejaculation, a disorder affecting up to 30% of men in Europe and the USA. There are currently no approved pharmaceutical treatments for premature ejaculation in the United States.