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Voltaren approved for arthritis pain over-the-counter in the US

Voltaren Arthritis Pain has been approved by the FDA as an over-the-counter product for the temporary relief of arthritis pain.

The US Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1 percent) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults 18 years and older. This means that Voltaren Arthritis Pain has become the first and only prescription-strength, non-steroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the US.

“For the millions of people around the world living with arthritis, joint pain and stiffness are daily realities,” said Franck Riot, Head of R&D at GlaxoSmithKline (GSK) Consumer Healthcare. “At GSK, we are committed to improving the quality of life of these people and today’s approval is progress towards this, providing consumers in the US with increased access to an effective, proven arthritis pain relief option. Voltaren is currently the number one OTC topical pain relief brand globally and we look forward to expanding its availability in the US.”

In addition, the Osteoarthritis Research Society International (OARSI) recently updated and expanded its guidelines for non-surgical management of osteoarthritis (OA) by developing patient-focused treatment recommendations. These updated guidelines recommend topical NSAIDs for individuals with knee OA. Of the non-core interventions assessed as part of this guideline update, topical NSAIDs were recommended more strongly than all oral analgesics due to favourable balance of consistent efficacy and minor transient side effects.

This approval was based on clinical data in hand and knee OA supporting the original prescription approval. The data demonstrated a consistent and appreciable onset of pain relief beginning as early as week one (as evidenced by appreciable improvements in pain symptoms across multiple pre-specified endpoints), the company said. 

Voltaren Gel, which GSK owns the rights to, is currently only available with a prescription in the US.