Sciele Pharma, Inc., a Shionogi Company, and Plethora Solutions Holdings PLC ("Plethora" - AIM:PLE), the specialist developer of products for the treatment and management of urological disorders, today announced the final analysis of its European Phase III double-blind placebo-controlled study of PSD502 for the treatment of premature ejaculation (’PE’). PSD502 has met not only its three co-primary endpoints of Intravaginal Ejaculation Latency Time (’IELT’) and Index of Premature Ejaculation (’IPE’; Ejaculatory Control and Sexual Satisfaction domains), but also all secondary endpoints.
The successful European study is one of two pivotal Phase III studies conducted in parallel with identical protocols. The second Phase III study is expected to be completed in the first half of 2009. Data from the two studies will be combined for submission for regulatory approval in the USA and Europe.
Phase III Study Details
Each Phase III study is a multicenter, randomized, double-blind, placebo-controlled efficacy study, and the program is expected to recruit a total of 540 patients across the two studies. Buy levitra without prescription Patients are treated for a 12-week period with an optional open-label phase of up to nine months.
The European study was conducted with 300 randomized patients across 32 investigational centers in four countries across Europe. Of these, 268 patients have now been entered into the optional nine-month open-label study.
European Phase III Study Outcome
Final analyses confirmed not only that PSD502 produced a highly clinically and statistically significant increase from baseline in all three co-primary study endpoints, but also in all secondary endpoints. The IELT for PSD502 was four minutes compared with one minute in placebo (pgeneric acomplia online buy | Buy viagra pills | Buy zithromax without prescription