Sciele Pharma and Plethora Solutions announced that a second Phase 3 study of PSD502 for the treatment of premature ejaculation (PE) has met all co-primary endpoints of Intra-vaginal Ejaculation Latency Time (IELT) and Index of Premature Ejaculation ((IPE) Ejaculatory Control, Sexual Satisfaction and Distress domains). This trial was the second of two, multi-center, randomized, double blind, placebo-controlled efficacy studies where patients were treated for a 12-week period with an optional open-label phase of up to nine months. Entirely consistent with the first study, analyses show that PSD502 produced a highly clinically and statistically significant increase from baseline in all co-primary study endpoints. The IELT was increased at least six-fold with PSD502 when compared to baseline (p<0.0001). There was a five-point difference between PSD502 and placebo in the IPE domains for ejaculatory control and sexual satisfaction (p<0.0001), where a two-point difference is considered clinically significant. There was a 2.5-point difference between PSD502 and placebo in the IPE domain for Distress (p<0.0001), where a two-point difference is considered clinically significant. As a secondary endpoint, partner satisfaction was also found to be considerably greater with PSD502 than placebo. The incidence of serious adverse events and overall side effects was similar in the PSD502 and placebo group. Overall, PSD502 was well tolerated and there were no systemic adverse events.
PSD502 is a proprietary formulation of two marketed drugs, lidocaine and prilocaine, dispensed by a metered dose aerosol.
For more information call (800) 461-3696 or visit www.sciele.com.