Ampio Pharmaceuticals, Inc. a company focused on new uses for previously approved drugs and New Molecular Entities (NMEs), announced that it has completed the analysis of the data from the phase III European clinical trials of Zertane, a repurposed drug used to treat Premature Ejaculation (PE). PE is the most common male sexual dysfunction, afflicting about 23% of all men between the ages of 18 and 75 years old. Zertane was acquired in the March, 2011 merger with DMI BioSciences, Inc.

“Completion of the phase III trials was particularly significant in that only about 15% of drugs that enter this phase have a successful outcome,” said Dr David Bar-Or, founder and chief scientific officer. “Further, the analysis of the trial results exceeded our expectations. The data showed positive statistical significance in every category analysed, with only very minor and minimal adverse events. This trial included 604 intent-to-treat patients, in a multi-centre, double-blind, placebo-controlled design.”

“Ampio currently holds issued patents in 31 countries worldwide and has multiple additional patent applications which seek to protect related clinical indications for the drug,” continued Dr Bar-Or. “This trial data is expected to allow Ampio to file a comprehensive application to selected European regulatory agencies to seek approval for commercialization of Zertane.”

Ampio CEO Donald Wingerter noted: “We continue to be very encouraged by the prospects for this unique product. In the near future, Ampio will provide a presentation of the trial results that will include comparisons to published data on the only other PE drug currently marketed in Europe as well as our commercial strategic plan for this product.”

The company is also performing a phase II clinical trial of Optina, a treatment for diabetic macular edema. Ampio Pharmaceuticals, Inc. develops innovative proprietary drugs for metabolic disease, eye disease, kidney disease, inflammation, CNS disease, and male sexual dysfunction.