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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

was observed in the incidence of withdrawal from the study by any treatment group (placebo and the two arms).

Vaughan Clift, MD, Chief Regulatory Officer of Ampio, clarified that …"Statistical analysis of the IELT results is complex. The patients' IELT distribution is positively skewed (non-normal distribution) and requires specific statistical tests and reporting of results. For example, reporting the average (mean) IELT is an inappropriate estimator of effect size. The median or geometric mean are both generally considered to be more acceptable. Most published studies on PE report either the mean IELT or the geometric mean IELT. We chose to report the medians because a median makes no assumption about the underlying distribution. For the purpose of comparison with other studies on Tramadol and dapoxetine (Priligy®), we also report the mean and the geometric mean of our results. A more recent evidence based definition was published by the International Society for Sexual Medicine (ISSM) in 2010 that defines lifelong PE as: "Ejaculation which always or nearly always occurs prior to or within one minute of vaginal penetration". Over 50% (314 patients) of the patients included in our study met the new clinical criteria."

Don Wingerter, Ampio's CEO noted that ..." We are very pleased with the results of this phase III clinical study which demonstrated both efficacy and no safety concerns for Zertane™ in treating PE.  We are aggressively pursuing regulatory approval for Zertane™ in Europe and are in discussions with potential distribution partners in Europe and Asia.  Equally important, our intellectual property that protects our commercialization of Zertane™ also encompasses combination products which combine Zertane™ with erectile dysfunction drugs (PDE5 inhibitors and others), so we believe our franchise in the clinical field of sexual dysfunction will be expanded."

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SOURCE Ampio Pharmaceuticals, Inc.
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