Premature ejaculation is a distressing male sexual dysfunction that is more common than erectile dysfunction (ED) and has a major impact on the quality of life for men and their sexual partners. Ampio Pharmaceuticals, Inc., a company focused on new uses for previously approved drugs and new molecular entities has completed analysis of the data from the Phase Three 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 company’s March, 2011 merger with DMI BioSciences, Inc.
“Completion of the Phase Three 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 analyzed, with only very minor and minimal adverse events. This trial included 604 intent-to-treat patients, in a multi-center, 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.”
The company, which recently commenced trading on the NASDAQ Capital Market under the ticker symbol “AMPE”, 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. By concentrating on development of new uses for previously approved drugs, approval timelines, costs and risk of clinical failure are reduced because these drugs have strong potential to be safe and effective while their shorter development times can significantly increase near term value. A key strategy includes actively exploring partnership, licensing and other collaboration opportunities to maximize Ampio’s product development programs.