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Lidocaine/Prilocaine Spray Effective, Safe for Men With Premature Ejaculation: Presented at AUA By Karen Shoffner CHICAGO -- April 29, 2009 -- A topical spray comprised of lidocaine 7.5 mg and prilocaine 2.5 mg (PSD502) appears to be a safe and effective treatment for premature ejaculation, according to results from a phase 3 study presented at the 2009 American Urological Association (AUA) Annual Meeting. Lead researcher Wallace Dinsmore, Royal Victoria Hospital, Belfast, Northern Ireland, presented the results of the double-blind, placebo-controlled study in a press briefing on April 28. The study included 300 men with premature ejaculation. One group of men applied the PSD502 spray to the glans of the penis 5 minutes before sexual intercourse while the other applied a placebo spray. Both groups had an intravaginal ejaculatory latency time (IELT) of less than 1 minute before the study. Efficacy was assessed by changes in IELT, Index of Premature Ejaculation (IPE), and Premature Ejaculation Profile. Subjects were followed up at intervals for 3 months and offered open-label treatment with PSD502 for a further 9 months. Preliminary analyses showed that PSD502 produced a highly clinically and statistically significant increase from baseline in all 3 coprimary endpoints. Both groups had a geometric mean baseline IELT of 0.6 minute, which increased to 4 minutes in the PSD502 group compared with 1 minute in the placebo group (P < .0001). There was a 7-point difference between PSD502 and placebo in the IPE domain for ejaculatory control (P < .0001) and a 6-point difference in the IPE domain for sexual satisfaction (P < .0001). Only 5 men in the PSD502 group reported any treatment-related adverse events compared with 1% in the placebo group. More than 260 men have opted to continue in the 9-month open-label study of the spray, said Dinsmore. [Presentation title: PSD502, A Novel Metered Dose Aerosol Formulation of Lidocaine and Prilocaine, Is a Safe and Effective Treatment for Premature Ejaculation (PE); Results of a Phase III, Randomized, Double-Blind, Placebo-Controlled Study. Abstract 1370] E-mail this page to a friend or colleague! To print, use this version