Sciele Pharma, Inc., a Shionogi community, and Plethora Solutions Holdings PLC (”Plethora” AIMPLE), the specialist developer of produce for the treatment and management of urological disorders, today announced the final analysis of its European Phase III doubleblind placebocontrolled study of PSD502 for the treatment of premature ejaculation (PE). PSD502 has met not only its three coprimary endpoints of Intravaginal Ejaculation Latency space (IELT) and Index of Premature Ejaculation (IPE; Ejaculatory qualification and Sexual Satisfaction domains), but conjointly all secondary endpoints.

The outstanding European study is one of two pivotal Phase III studies conducted in parallel with identical protocols. The duplicate Phase III study is expected to be completed in the first half of 2009. measurements 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, doubleblind, placebocontrolled efficacy study, and the program is expected to recruit a total of 540 patients crosswise the two studies. Patients are treated for a 12week period with an optional openlabel phase of up to nine months.

The European study was conducted with 300 randomized patients cross 32 investigational centers in four countries opposite Europe. Of these, 268 patients have now motheaten entered into the optional ninemonth openlabel study.

European Phase III Study Outcome

Final analyses confirmed not only that PSD502 produced a highly clinically and statistically significant cumulation from baseline in all three coprimary study endpoints, but furthermore in all secondary endpoints. The IELT for PSD502 was four minutes compared with one minute in placebo (p