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Voltaren Gel: First FDA-approved topical prescription treatment for osteoarthritis

Posted on Fri, September 26, 2008 at 10:28 am

From www.pharmacist.com

FDA has recently approved diclofenac sodium gel (Voltaren Gel—Novartis) 1% as the first topical nonsteroidal anti-inflammatory prescription treatment for osteoarthritis joint pain. Osteoarthritis, which affects approximately 21 million Americans, is a chronic condition characterized by the break down of cartilage in joints.

The efficacy and safety of diclofenac gel have been studied in more than 900 osteoarthritis patients suffering from hand and knee pain. The U.S. approval was based on several studies, including the results of two randomized, double-blind, placebo-controlled, efficacy studies and a 12-month safety study. Significant and sustained reductions in hand and knee osteoarthritis pain have been demonstrated with diclofenac gel; pain levels were reduced by 46% after 6 weeks of treatment in an efficacy study of patients with osteoarthritis of the hand.

"The combination of benefit and safety provides a welcome new treatment approach for osteoarthritis, offering patients an alternative to oral therapies," said Roy Altman, MD, Professor of Medicine in the Division of Rheumatology and Immunology at the University of California at Los Angeles, in a news release. "Voltaren Gel delivers the proven efficacy of diclofenac with significantly less systemic absorption, minimizing the risk of side effects."

Diclofenac gel has not been evaluated for safety and efficacy for use on joints of the spine, hip, or shoulder, according to the product labeling. Skin reactions at the application site, reported by 7% of patients in the clinical trials, were the most common adverse events associated with the product. Voltaren Gel is available in 100 g tubes.

For more information on Voltaren Gel, please visit the following links:

http://www.voltarengel.com

http://arthritis.about.com/b/2007/11/11/voltaren-gel-10-things-you-need-to-know.htm

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