Ampio Contracts with Syngene to Manufacture Zertane-ED, its Recently Patented Combination Drug

Ampio Pharmaceuticals, Inc. AMPE today announced that it is proceeding with the development plan for a combination product to treat both premature ejaculation (PE) and erectile dysfunction (ED). The positive pre-IND meeting in June with the FDA gave the company clear guidance for the two concurrent pivotal trials necessary for approval of Zertane™ to treat PE in the USA. Vaughan Clift, MD, Ampio's Chief Regulatory Officer, noted "Contrary to rumors that the FDA did not recognize PE as a treatable ailment, the FDA has expressly adopted the definition of PE as a disease condition, using the definition of Premature Ejaculation provided by the International Society for Sexual Medicine (ISSM) Ad Hoc Committee (i.e., premature ejaculation is characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration and/or the avoidance of sexual intimacy.*) This definition fully complements and encompasses the clinical results from its successful Phase 3 studies of Zertane™ conducted in Europe which was reported in the prestigious journal European Urology."