Xanodyne Pharmaceuticals, Inc. Receives Approvable Letter From the U.S. FDA for ZIPSOR(TM) Capsules
“Xanodyne is pleased with this action and will work closely with the FDA to provide a complete response. Importantly, no additional clinical trials have been requested,” said Gregory D. Flexter, President and Chief Executive Officer of Xanodyne. Zipsor is a unique formulation designed for rapid and consistent release while minimizing systemic exposure.
Xanodyne submitted a New Drug Application (NDA) for Zipsor to the FDA in September 2007. The NDA included data from four Phase 3 clinical trials of Zipsor in patients with acute pain following bunionectomy or dental surgery in which Zipsor achieved the primary efficacy endpoint of the trial, and was well-tolerated.
About Xanodyne
Xanodyne Pharmaceuticals, Inc., which commenced operations in 2001, is an integrated specialty pharmaceutical company with both development and commercial capabilities focused on women’s healthcare and pain management. Xanodyne markets a portfolio of revenue generating products consisting of FDA approved pharmaceuticals and a line of prenatal vitamins. Additionally, Xanodyne is advancing a late stage pipeline of product candidates targeted at significant potential markets in Xanodyne’s focus areas.
Contact:
Xanodyne Pharmaceuticals, Inc. Stephen A. Stamp, CFO 859-342-2055
Source: Xanodyne Pharmaceuticals, Inc.