Journal of Drugs in Dermatology - Diclofenac sodium topical gel for osteoarthritis
The FDA recently granted approval to Novartis to manufacture and market Voltaren[R] gel. Voltaren gel (diclofenac sodium 1% gel) is approved for the use of pain relief due to osteoarthritis of the knees and hands. The product was initially evaluated in a 12-week, randomized, double-blind clinical study of 246 patients. Results showed that 4 g of Voltaren gel used 4 times each day on the knee decreased mean pain intensity relative to a placebo as measured by a standardized pain rating index. A subsequent 8-week randomized double-blind trial of 385 patients demonstrated that 2 g of Voltaren gel per hand used 4 times daily significantly reduced mean pain intensity when compared to a placebo.
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Side effects of treatment included application site reactions. The recommended dose of Voltaren gel is 4 g applied 4 times daily over joints of the lower extremities and 2 g applied 4 times daily over joints of the upper extremities. Total dose over all affected areas should not exceed 32 g/day.
Marissa Heller MD
Department of Dermatology, Boston University School of Medicine
Pipeline Previews brings you information on the newest drugs and medical products as they become available to the dermatologic community, including additional information from the manufacturers and physicians who wish to share their clinical experience with these new products. We will also inform you about the latest drugs receiving FDA approval.
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COPYRIGHT 2008 Gale, Cengage Learning
