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Press Release: Voltaren® Gel receives US regulatory approval as the first approved topical prescription treatment for pain associated with osteoarthritis
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Basel, October 22, 2007 - Voltaren® Gel (diclofenac sodium topical gel) 1% has received US regulatory approval as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis.
The US Food and Drug Administration (FDA) granted the approval for Voltaren Gel, which is a non-steroidal anti-inflammatory (NSAID) medication, for use in treating pain associated with osteoarthritis in joints amenable to topical treatment, such as the knees and those of the hands.
Osteoarthritis is a chronic condition characterized by the breakdown of cartilage in the joint.
Clinical trials have demonstrated Voltaren Gel to be highly effective in treating osteoarthritis pain in the hands and knees, which are the body's most commonly affected joints. It is the first topical osteoarthritis treatment to have proven its effectiveness in both the hands and knees through clinical trials.
Voltaren Gel, which will be marketed in the US by the OTC business unit since this is the case in many other countries, delivers effective pain relief with a favorable safety profile as its systemic absorption is 94% less than the comparable oral diclofenac treatment.
"Voltaren Gel is proven to be effective for osteoarthritis of the hand and knee and has a favorable safety profile. 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 UCLA in Los Angeles and Past President of the Osteoarthritis Research Society International. "Voltaren Gel delivers the proven efficacy of diclofenac with significantly less systemic absorption, minimizing the risk of side effects."
The efficacy and safety of Voltaren Gel were studied in more than 900 patients with knee or hand osteoarthritis. The US approval was based on several studies, including the results of two randomized, double-blind, placebo-controlled efficacy studies and a 12-month safety study.
Voltaren Gel was shown to significantly reduce pain in hand and knee osteoarthritis, with pain relief sustained through the end of treatment. After six weeks of treatment in an efficacy study of patients with osteoarthritis of the hand, results showed that pain levels were reduced by nearly half (46%). In a 12-week study in patients with osteoarthritis of the knee, Voltaren Gel showed a 51% reduction in pain.
"Voltaren Gel represents an important clinical milestone - it is the first prescription topical treatment in the US shown to relieve osteoarthritis pain and to clinically prove efficacy in treating both the knees and hands," said Jorge Insuasty, MD, Senior Vice President, Research and Development in the Group's OTC business unit. "Patients now have the option to effectively treat osteoarthritis pain at the source with favorable tolerability."
Voltaren Gel gets FDA approval for topical OA management
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