FDA Approves Voltaren Arthritis Pain as OTC Topical Gel for Osteoarthritis


The gel is intended to relieve join pain in the hand, wrist, elbow, foot, ankle, or knee.


The US Food and Drug Administration (FDA) approved GlaxoSmithKline’s Voltaren Arthritis Pain as an over-the-counter product for relief of arthritis pain.

The FDA approval makes Voltaren Arthritis Pain (diclofenac sodium topical gel 1%) the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel available over the counter in the US. Diclofenac sodium is an effective medicine clinically proven to relieve joint pain and the topical gel serves as an alternative to oral analgesics for the treatment of osteoarthritis.

Voltaren Arthritis Pain reduces substances in the body that cause pain and inflammation. The gel is intended for temporary relief of joint pain in the hand, wrist, elbow, foot, ankle, or knee as a result of osteoarthritis, the most common type of arthritis.

International and US medical societies, including the 2019 American College of Rheumatology endorse the early use of topical NSAIDs for treating arthritis pain, Roy Altman, MD, a professor of medicine in rheumatology at UCLA, said.

The gel was approved based on clinical data in hand and knee osteoarthritis. The data demonstrated a consistent and significant onset of pain relief as early as 1 week.

Voltaren targets pain at the source to treat arthritis pain, unlike other topicals which typically heat, cool, or irritate the surface of the skin, masking the pain.

The FDA initially approved Voltaren Arthritis Pain, previously Voltaren Gel 1%, in 2007 as a prescription drug indicated for the relief of the pain of osteoarthritis of joints responsive to topical treatment.

The topical gel may take up to 7 days to work and if an individual’s pain does not improve after 3 weeks, they should seek medical attention.

The approval is progress towards improving the quality of life of patients living with joint pain and stiffness due to arthritis, Franck Riot, MBA, head of R&D at GlaxoSmithKline Consumer Healthcare, said.

“Voltaren is currently the number 1 over-the-counter topical pain relief brand globally, and we look forward to expanding its availability in the US,” Riot said.

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