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, Novartis Consumer Health, Inc. "Patients now have the option to effectively treat osteoarthritis pain directly at the source with favorable tolerability."
Approximately 21 million people in the US have osteoarthritis,(1) and the aging population in the US means 72 million more will be at risk for developing the condition by 2030.(2) Osteoarthritis is a chronic, painful condition that often leads to working limitations and reduced overall health.(3)
Osteoarthritis is a chronic condition characterized by the breakdown of
cartilage in the joint. Cartilage cushions the ends
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