logo
Share SHARE
FONT-SIZE Plus   Neg

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

Ampio Pharmaceuticals, Inc. (AMPE: Quote) 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
Internet giant Google Inc. (GOOGL, GOOG) has launched a new online flight search tool that makes it easy to find out the best flight deal. The tool dubbed "Google Flights" provides a calendar that one can scroll through and see the lowest fare highlighted for each day. One can also use the lowest... Hyperloop Transportation Technologies, a start-up that has adopted Elon Musk's ambitious project of high-speed transportation system, plans to build a Hyperloop test track in California and completed as early as 2016. Hyperloop Test Technologies, a crowd-funded company, plans to take Musk's dream... Colors have set the social media afire after an otherwise innocuous photo of a bodycon dress kept users guessing as to what hues permeate it. Opinions are divided, with some seeing the dress as white and gold, and others as blue and black. The photo was posted on Tumblr by a user called Swiked.
comments powered by Disqus
RELATED NEWS
Trade AMPE now with 
Follow RTT