Ampio requests Pre IND Meeting for Zertane™ Print E-mail
By Staff and Wire Reports   
Monday, 09 April 2012 07:59
Ampio Pharmaceuticals, Inc. (NASDAQ:AMPE), the company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), announced that it had 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."

Zertane™, one of several drugs in the company's pipeline, is a repurposed oral drug to treat premature ejaculation. The active ingredient in Zertane™ has multiple mechanisms of actions that can delay ejaculation. This drug also has an excellent safety record established during 30 years of human use for other medical indications. These unique pharmaceutical qualities, exceptional human safety record, and a distinctive non-standard dosage not available in generic form, differentiate Zertane™ from other treatments for premature ejaculation. Zertane™ is taken as needed before sexual activity, and is not required on a daily basis.

In an interview with BioMedReports, Ampio's CEO, predicted that 2012 would be the yearhis firm would prove that their drugs really work. “We expect very good results and believe they will be the stepping stone for this company,” explained Macaluso.  “We hope to move into the future with a much higher valuation.”

Ampio's shares had traded as low as $2.57 after the company became the target of short selling funds which had published factually inaccurate and materially misleading information about the firm. Various anonymously published articles crippled the stock price and injured the reputation of the company before regulators launched their own investigation into the matter following reports about the alleged market manipulation. One regulatory agency has continued to investigate the actions against the firm. Recently, the firm anounced statistically significant improvement in pain relief from their drug candidate Ampion™ in clinical trials.

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