Xanodyne Receives Approvable Letter From the U.S. Food and Drug Administration for ZIPSORTM (diclofenac potassium) Capsules New Product Candidate for Pain
NEWPORT, Ky.--(BUSINESS WIRE)--Xanodyne Pharmaceuticals, Inc. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for Zipsor, its candidate for the treatment of patients with mild to moderate acute pain. Zipsor is a proprietary immediate release liquid-filled soft gelatin capsule containing 25 mg of diclofenac potassium for oral administration.
"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.
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.