FDA Approves Zipsor
Xanodyne Receives Approval From the U.S. Food and Drug Administration for Zipsor (diclofenac potassium) Liquid Filled Capsules
NEWPORT, Ky., June 17, 2009 /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.
Like all prescription non-steroidal anti-inflammatory drugs (NSAIDs), Zipsor may increase the chance of a heart attack or stroke that can lead to death. Zipsor should not be used right before or after certain heart surgeries. Serious skin reactions or stomach and intestine problems, such as bleeding and ulcers, can occur without warning and may cause death. Patients taking aspirin or other blood thinners and the elderly are at increased risk for stomach bleeding and ulcers. Tell your doctor about all of the medications you take and all of your medical conditions prior to taking Zipsor, especially if you are pregnant, have a history of ulcers or bleeding in the stomach or intestines, have high blood pressure or heart failure or heart disease, or have kidney or liver problems. People with aspirin-sensitive asthma or allergic reactions due to aspirin or other NSAIDs should not take Zipsor. Prescription Zipsor should be used exactly as prescribed at the lowest possible dose for the shortest time needed. For additional important information about Zipsor see the FDA-approved medication guide or the full prescribing information.
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 prescription 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: Nathan McCutcheon of Xanodyne Pharmaceuticals, Inc.,+1-859-342-3325
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Posted: June 2009