Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE—News) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), announced today that it submitted to the FDA a pre IND package on Zertane™, its on-demand premature ejaculation drug, for a meeting and discussion on the approval path under the 505(b) 2 regulation/registration requirement in the US.
Michael Macaluso, Ampio's CEO, noted that "Zertane™ successfully completed two phase II and two phase III studies in Europe that met all end points including efficacy and safety. A follow on 12 weeks open label study of 101 patients demonstrated no abuse potential or dependency."
Mr. Macaluso continued, "Ampio is currently in discussions with potential partners for the distribution of Zertane™ and Zertane™ in combination with an erectile dysfunction drug. These negotiations require clarity about the appropriate regulatory path to commercialization in the United States and so we are seeking the FDA's guidance."
Ampio Pharmaceuticals, Inc.