From Earlier: Ampio Reports Successful Type B Pre-IND Meeting with the FDA for its Drug Zertane™ to treat Premature Ejaculation (PE)

Ampio Pharmaceuticals, Inc.

announced today the outcome of its pre-IND meeting with the CDER Urology and Reproductive group (DRUP) division of the FDA that took place on June 20, 2012. The FDA provided all the necessary guidance on the design and conduct of two concurrent phase III pivotal clinical trials of approximately 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 (PE) as defined by the International Society of Sexual Medicine. These clinical trials would qualify Zertane™'s registration/clearance under the 505(b) 2 regulatory pathway in the US.