Ampio Pharmaceuticals, Inc. (AMPE) announced the outcome of its pre-IND meeting with the CDER Urology and Reproductive group division of the U.S. Food and Drug Administration, or FDA, that took place on June 20, 2012.
FDA gave all the necessary guidance on the design and conduct of two concurrent phase III pivotal clinical trials of around 15 weeks duration. Successful completion of these trials, powered adequately (based on the phase 3 European trials), will allow for FDA clearance to market Zertane as a treatment for life-long premature ejaculation, or PE. These clinical trials would qualify Zertane's registration/clearance under the 505(b) 2 regulatory pathway in the US, the company noted.
Michael Macaluso, Ampio's chief executive officer, said, "We could not be more pleased, as the FDA guidance gave us a clear path to progress our Zertane™ drug through clinical development rapidly, with procedures that permit prompt resolution of the few outstanding issues, so we could commence the trials by the end of this year. This positive guidance will allow us to formalize our negotiations with potential partners. This productive meeting with the FDA was expected by the company because Zertane already successfully completed two phase II and two phase III trials in Europe that met all end points including efficacy and safety."
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