logo
Share SHARE
FONT-SIZE Plus   Neg

Ampio Pharma Submits Type B Pre IND Meeting Request To FDA For Zertane

Ampio Pharmaceuticals, Inc. (AMPE) said 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.

Zertane is a repurposed oral drug to treat premature ejaculation, a condition that has a major impact on the quality of life for men and their sexual partners.

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."

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."

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Philip Morris International Inc. has filed an application with the U.S. Food and Drug Administration to market a new type of cigarette that holds potentially less health risks than conventional cigarettes. The new type of cigarette electronically heats tobacco to produce a vapor without burning it, making it less harmful. Apple Inc. has confirmed that the iPhone 6s battery issue may be larger than thought, as the tech giant said that some customers "outside the affected range of devices" have also reported unexpected shutdowns. The company again stressed that it is not a security issue. Tesla Motors Inc. voluntarily recalled more than 7000 charging adapters. The company said these adapters of Nema 14-30, 10-30 and 6-50 are sold separately as accessories. Earlier in November, two customers had complained about overheating issue of Nema 14-30 charging adapters. Tesla confirmed in its recall communication that there were no other similar incidents or reports of injuries or proper
comments powered by Disqus
Follow RTT