Ampio Pharma (AMPE) Reports Positive Data from Zertane Phase III in Patients with PE

Ampio Pharmaceuticals, Inc. (Nasdaq: AMPE),reports 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.

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