Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

RELATED NEWS
Trade AMPE now with 
4/9/2012 7:29 AM ET

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."

Click here to receive FREE breaking news email alerts for Ampio Pharmaceuticals, Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Justin Moore has been named Humanitarian of the Year by by the Armed Forces Foundation. Moore received the award alongside Big Machine Label Group President/CEO Scott Borchetta for their service and commitment to the morale and welfare of military families through the Crown Royal "Your Hero's Name Here" contest. International Business Machines Corp. said Wednesday after the markets closed that its first quarter profit fell 21% from last year, hurt by lower revenue as well as a hefty workforce rebalancing charge. The company's quarterly earnings per share, excluding items, came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. Stocks moved sharply higher over the course of the trading day on Wednesday, further offsetting the steep losses posted late last week. The markets benefited from a positive reaction to the latest earnings news as well as remarks by Federal Reserve Chairman Janet Yellen. The major averages saw further upside going into the close, ending the session at their best levels of the day.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.