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Ampio Announces Positive Results From 12-Week Open Label Extension Study of Zertane™ in Patients With Premature Ejaculation.
Date:9/26/2011

GREENWOOD VILLAGE, Colo., Sept. 26, 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 positive results from a 12-week open label extension study that was performed at the conclusion of the Phase III trials for Zertane™ in patients with premature ejaculation.  No treatment-related serious adverse events and very few adverse events were recorded during the open-label extension period, when all subjects received active treatment, even though the mean extent of exposure (approximately 0.26 to 0.31 tablets per day) appeared to increase modestly compared to the double-blind treatment period (approximately 0.24 to 0.26 tablets per day). The average use by patients during this 12 week period remained less than 3 pills per week.  Six subjects experienced an adverse event (5.9%) with only one treatment-related adverse event (anxiety/erectile dysfunction), demonstrating that even the higher dose of Zertane™ proves to be safe with a longer follow-up. There were no reports of dependency or tolerability issues.

"These findings of safety during an extended period of time beyond our Phase III clinical trial in men with premature ejaculation help diminish any potential concerns about safety or dependency with the use of the active ingredient of Zertane™," said Don Wingerter, Ampio CEO.

About the Study

The two Phase III trials for Zertane™ were conducted in 62 sites and 11 countries in Europe (results recently published in European Urology). In the open label extension trial, all subjects participating in this study (n=101) received the higher dose of Zertane™ (89 mg), and were evaluated at 3-week intervals for a total of four visits. Safety data col
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SOURCE Ampio Pharmaceuticals, Inc.
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