Xanodyne Pharmaceuticals, Inc.has received approval from the FDA for Zipsor (diclofenac potassium) Liquid Filled Capsules,a new treatment option indicated for relief of mild to moderate acute pain inadults (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 approvedbased on the demonstration of safety and efficacy in two well controlledpost-surgical bunionectomy clinical trials and accomplished this with thelowest available dose (25 mg) of any currently marketed diclofenac potassiumproduct in the United States. It will also be the first and only prescriptionstrength NSAID for oral administration available for the U.S. market in aliquid-filled soft gelatin capsule,” continued Dr. Shangold. The low recommended total daily dose of diclofenac potassium deliveredwith Zipsor aligns with current guidance from the FDA recommending utilizationof NSAIDs at the lowest effective dose, for the shortest amount of time.Zipsor was generally well-tolerated and demonstrated efficacy in two multipledose post-surgery (bunionectomy) clinical trials. At baseline, Zipsorpatients had an average pain intensity of 6.9 (on a 0 to 10 numeric painrating scale). “Demonstrating efficacy at a low dose not previously available to themarket presents an important new therapeutic option to the physician and asignificant opportunity for Xanodyne. It is also a significant milestone forour company as Zipsor represents the first approval to come out of our R&Dorganization. We are completing our launch preparations and our expectationis to have Zipsor on the US market within the coming months,” said MichaelValentino, President and Chief Executive Officer.
