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."