Sciele Pharma, part of Japan's Shionogi, and the UK's Plethora Solutions presented results from a Phase III randomized, double-blind, placebo-controlled study of PSD502 (lidocaine/prilocaine) metered-dose aerosol for the treatment of premature ejaculation at the American Urological Association's annual meeting.
Final analyses confirmed that PSD502 produced a highly clinically- and statistically-significant increase from baseline in all three co-primary study endpoints, and also in all secondary endpoints. Of patients who received the drug, 91% achieved an intravaginal ejaculatory latency time of greater than one minute and 75% achieved greater than two minutes, compared with only 54% and 22% of placebo patients, respectively. The treatment was rated positively by 86% of patients compared with 34% on placebo.
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