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

Editors Pick
Fortune has once again named Google Inc. (GOOG, GOOGL) as the best company to work for, with Twitter Inc. (TWTR) also joining the annual list for the first time. This is for the sixth time and for the fourth consecutive time that Google has ranked No.1 in the Fortune's annual list of "100 Best Companies... Dunkin' Donuts has agreed to remove a whitening agent called titanium dioxide, commonly a source of nanomaterials, from all powdered sugar used in its donuts. The move follows pressure from advocacy group As You Sow, which put a shareholder proposal asking Dunkin' to reduce the risks of using nanomaterials in its food products. Warren Buffett's Berkshire Hathaway is reportedly planning its first ever European bond sale of 3 billion euros to take advantage of low interest rates in the region, traversing a path taken by a range of home companies in search of cheap funding options. The move comes as the European Central Bank's bond-buying stimulus program of 60 billion euros a month is imminent.
comments powered by Disqus
RELATED NEWS
Trade AMPE now with 
Follow RTT