Phase III trial for premature ejaculation agent meets endpoints

A second and final phase III, multicenter, double-blind, placebo-controlled study of PSD502 for premature ejaculation treatment has met all endpoints, according to Sciele Pharma and Plethora Solutions Holdings. Those endpoints include intra-vaginal ejaculation latency time and the index of premature ejaculation (IPE; ejaculatory control, sexual satisfaction, and distress domains).

The study of patients from the U.S., Canada, and Europe is the second of two phase III studies with identical protocols. Data from the 540-patient studies will be combined in seeking regulatory approval in the U.S. and Europe.

Patients were treated for 12 weeks, with an optional open-label phase of up to 9 months. Results indicated that the intra-vaginal ejaculation latency time (IELT) was increased at least six-fold with PSD502 compared with baseline (pp