FDA Approves Prescription Arthritis Pain Treatment for OTC Use

The FDA has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%, GlaxoSmithKline), a nonsteroidal anti-inflammatory drug (NSAID) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults. Voltaren Arthritis Pain becomes the first prescription-strength NSAID topical gel for arthritis pain to be available over the counter in the United States.

Diclofenac sodium is clinically proven to relieve joint pain due to arthritis. Voltaren Arthritis Pain penetrates through the skin and targets pain directly at the site. The amount of diclofenac sodium that is systemically absorbed from Voltaren Arthritis Pain is on average 6% of the systemic exposure from an oral form of diclofenac sodium. Currently, Voltaren gel is only available with a prescription.

“Osteoarthritis treatment guidelines from several international and United States medical societies, including the 2019 American College of Rheumatology, endorse the early use of topical NSAIDs for treating arthritis pain of the knee and hand,” said Roy Altman, MD, a professor of medicine in rheumatology at the University of California, Los Angeles, in a press release. “In contrast to prior guidelines, the recommendations are inclusive of all age groups, not just the elderly.”

The submission in support of diclofenac sodium topical gel, 1% was based on clinical trial data on hand and knee osteoarthritis that supported the original prescription approval. The data demonstrated consistent and appreciable onset of pain relief beginning as early as week 1 (as shown by appreciable improvements in pain symptoms across multiple prespecified end points), according to GlaxoSmithKline.