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Ampio Pharmaceuticals, Inc. Releases Results From Phase III Clinical Trial of Zertane™ for the Treatment of Premature Ejaculation (PE), the Most Prevalent Form of Male Sexual Dysfunction
Date:6/27/2011

GREENWOOD VILLAGE, Colo., June 27, 2011 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE - News) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs") today announced results of its phase III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of two doses of Zertane™ for the treatment of premature ejaculation (PE). The study was conducted in 61 sites in 11 countries in Eastern and Western Europe and included 604 intent-to-treat patients.

The presence of PE for patient inclusion in this study was confirmed by the measurement of baseline Intravaginal Ejaculatory Latency Time (IELT) in accordance with the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, text revision (DSM IV TR) which defines PE as a lifelong condition with an IELT of less than 2 minutes. The prevalence of PE is estimated to be 2% of the male population (for the less than 1 minute IELT (1)) rising to 23% (for the less than 2 minute IELT (2)).

The two study efficacy end points were: (1.) Statistically significant prolongation of IELT (defined as the time from vaginal penetration to ejaculation in minutes) compared to placebo.  (2.) Statistically significant improvements in the Premature Ejaculation Profile scores (PEP, which is an accepted and validated questionnaire for the evaluation of the impact on patients with PE and their partners) compared to placebo.  A brief summary of the results follow:

  • Zertane™ at the lower dose increased the median IELT 2.37 fold over baseline. The mean increase was 4.07 fold over baseline. Geometric mean increase was 2.3 fold over baseline. For comparison purposes dapoxetine (Priligy®) at the lower dose increased geometric mean by 2.0 fold over
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SOURCE Ampio Pharmaceuticals, Inc.
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