Novartis Pharmaceuticals AG (BASEL, Switzerland) announced that Voltaren® Gel (diclofenac sodium topical gel) 1% has received US FDA regulatory approval as the first topical nonsteroidal anti-inflammatory drug (NSAID) prescription treatment for use in treating pain associated with osteoarthritis (OA) in joints amenable to topical treatment, such as the knees and those of the hands.

The efficacy and safety of Voltaren Gel were studied in more than 900 patients with knee or hand OA. 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. The gel was shown to significantly reduce OA hand and knee pain, with pain relief sustained through the end of treatment. After 6 weeks of treatment in an efficacy study of patients with OA of the hand, results showed that pain levels were reduced by 46%. In a 12-week study in patients with OA of the knee, results showed a 51% reduction in pain.

Voltaren Gel, which will be marketed in the US by Novartis' OTC business unit, delivers effective pain relief with a favorable safety profile as its systemic absorption is 94% less than the comparable oral diclofenac treatment. The most common adverse reactions reported in clinical trials were application site reactions in 7% of treated patients. Voltaren Gel should not be used in combination with oral NSAIDs or aspirin because of the potential for increased adverse effects. Similarly, combined use of the gel with other topical products, such as sunscreens and cosmetics, on the same skin area has not been tested and should be avoided because of the potential to alter local tolerability and absorption.