Xanodyne Receives Approval From the U.S. Food and Drug Administration for ZIPSOR(TM) (diclofenac potassium) Liquid Fille... ( NEWPORT Ky. June 17 /- Xanodyne Pharm...)

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Xanodyne Receives Approval From the U.S. Food and Drug Administration for ZIPSOR(TM) (diclofenac potassium) Liquid Filled Capsules

Date:6/17/2009

NEWPORT, Ky., June 17 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc. announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for Zipsor (diclofenac potassium) Liquid Filled Capsules, a new treatment option indicated for relief of mild to moderate acute pain in adults (18 years of age or older).

"Zipsor is a drug with several unique features," said Gary A. Shangold, Chief Medical Officer of Xanodyne. "It is the first NSAID to be approved based on the demonstration of safety and efficacy in two well controlled post-surgical bunionectomy clinical trials and accomplished this with the lowest available dose (25 mg) of any currently marketed diclofenac potassium product in the United States. It will also be the first and only prescription strength NSAID for oral administration available for the U.S. market in a liquid-filled soft gelatin capsule," continued Dr. Shangold.

The low recommended total daily dose of diclofenac potassium delivered with Zipsor aligns with current guidance from the FDA recommending utilization of NSAIDs at the lowest effective dose, for the shortest amount of time. Zipsor was generally well-tolerated and demonstrated efficacy in two multiple dose post-surgery (bunionectomy) clinical trials. At baseline, Zipsor patients had an average pain intensity of 6.9 (on a 0 to 10 numeric pain rating scale).

"Demonstrating efficacy at a low dose not previously available to the market presents an important new therapeutic option to the physician and a significant opportunity for Xanodyne. It is also a significant milestone for our company as Zipsor represents the first approval to come out of our R&D organization. We are completing our launch preparations and our expectation is to have Zipsor on the US market within the coming months," said Michael Valentino, President and Chief Executive Officer.

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