Premature ejaculation agent meets primary endpoints in phase III study

A European phase III double-blind placebo-controlled study of PSD502, a proprietary formulation of lidocaine and prilocaine for the treatment of premature ejaculation, has met its three co-primary endpoints of intra-vaginal ejaculation latency time (IELT) and index of premature ejaculation (IPE), Plethora Solutions Holdings PLC has announced.

The study included 300 randomized patients across 32 investigational centers in four countries. Of these, 265 patients also entered an optional 9-month open-label study.

Initial analyses show that PSD502 produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints. The IELT geometric mean for PSD502 was 4 minutes compared with 1 minute for placebo (ppp
Only 2.6% of patients reported treatment-related adverse events, according to a Plethora Solutions statement.

A second phase III study is being conducted in North America and is expected to be complete in the first half of 2009. Once the results from the U.S. phase III study become available, data from the two studies will be combined for submission for regulatory approval in the United States and Europe.