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Warren-based GlaxoSmithKline announced on Monday the U.S. Food and Drug Administration (FDA) approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1 percent arthritis pain reliever) 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.  

According to GSK, with the FDA’s approval, Voltaren Arthritis Pain becomes the first and only prescription-strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the United States.

Voltaren Gel, which GSKCH owns the rights to, is currently only available with a prescription in the US. Today’s OTC approval of Voltaren Arthritis Pain will provide the nearly 30 million Americans with osteoarthritis over-the-counter access to this topical treatment option.

Franck Riot, head of R&D, GSK Consumer Health Care said: “For the millions of people around the world living with arthritis, joint pain and stiffness are daily realities. 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 U.S. with increased access to an effective, proven arthritis pain relief option. Voltaren is currently the number 1 OTC topical pain relief brand globally, and we look forward to expanding its availability in the U.S.”

In addition, the Osteoarthritis Research Society International (OARSI) recently updated and expanded its guidelines for non-surgical management of OA by developing patient-focused treatment recommendations. These updated guidelines strongly recommend topical non-steroidal anti-inflammatory drugs (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 favorable balance of consistent efficacy and minor transient side effects.

The submission in support of Monday’s approval of Voltaren Arthritis Pain 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 1 (as evidenced by appreciable improvements in pain symptoms across multiple pre-specified endpoints).