FDA accepts Ampio’s Patient Outcome for Premature Ejaculation questionnaire

Mar 11 2013

Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE), a biopharmaceutical company developing drugs to treat prevalent inflammatory diseases, such as osteoarthritis (Ampion™) and diabetic macular edema (Optina™) and sexual dysfunction (Zertane™) announced FDA acceptance of its POPE questionnaire, a modification of the Premature Ejaculation Profile (PEP) questionnaire that was used in the two successful Zertane™ Phase 3 clinical trials completed in Europe.

Dr. Vaughan Clift , Ampio's Chief Regulatory Officer, explained, "This unique evaluation tool, named Patient Outcome for Premature Ejaculation (POPE), was tested in a clinical trial to assure the FDA's SEALD division that the verbal responses of the patients to physician questions following their treatment would accurately reflect their clinical response to the drug. The successful completion of this trial and acceptance of the POPE by the FDA allows Ampio (or a pharmaceutical partner) to file an IND in the USA for a pivotal trial of Zertane™ with POPE as a co-primary end-point along with Intravaginal Ejaculatory Latency Time (IELT). This critically important improvement of the clinical trial protocol has occupied the company for the last seven months and we are grateful to the FDA for its assistance and guidance during this facet of the regulatory path."

Michael Macaluso , Ampio's CEO, noted that "Ampio will be the sole owner of the POPE, the only FDA accepted outcome measure of efficacy of treatment for PE and a requirement by the FDA for any clinical trial evaluating treatment of PE together with the other co-primary end-point, Intravaginal Ejaculatory Latency Time (IELT). The Zertane™ pivotal trial in the USA is estimated to cost less than $4 million. The drug has already been manufactured and ready for the trial. The CMC created for Zertane™ is also being submitted to the TGA (the Australian FDA) as the last piece for registration of Zertane™ in Australia."

Mr. Macaluso further noted, "The Ampio sexual dysfunction portfolio also includes Zertane-ED™, a combination of Zertane™'s active ingredient with an erectile dysfunction drug to treat comorbid PE and Erectile Dysfunction (ED). Men with ED suffer from PE about 30% of the time. Zertane-ED™ is under development by Ampio and has been formulated so that the peak activities of its two components (PE and ED) are synchronous. Ampio was awarded multiple patents on the combinations of Zertane™ with any PDE5 inhibitors. Additionally, Daewoong Co. Ltd, our South Korean partner, has agreed to finance and conduct the first clinical trial on Zertane-ED™ in Korea in compliance with FDA requirements. With everything in place for Zertane™ and a very low cost pivotal trial, all options are open to us and we can make the best possible decision for our shareholders."