The FDA approval provides OTC access to the Voltaren Arthritis Pain, which has been available only with a prescription in the US
GlaxoSmithKline head office, London (Credit: Ian Wilson/Wikipedia.)
UK-based pharmaceutical firm GlaxoSmithKline (GSK) has secured the US Food and Drug Administration (FDA) approval for its Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% NSAID).
Voltaren Arthritis Pain has been indicated 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 aged 18 years and above.
GSK consumer healthcare R&D head Franck Riot 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 US 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 US.”
Voltaren Arthritis Pain is the first OTC NSAID topical gel for arthritis pain in the US
The FDA approval provides OTC access to the GSK’s topical treatment, which has been available only with a prescription in the US.
GSK said that the FDA approval makes Voltaren Arthritis Pain as the first and only prescription-strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the US.
The Osteoarthritis Research Society International (OARSI) has recently expanded its guidelines for non-surgical management of osteoarthritis (OA) through patient-focused treatment recommendations.
In addition, the new guidelines are said to recommend topical non-steroidal anti-inflammatory drugs (NSAIDs) for individuals with knee OA.
GSK said that the regulatory approval of Voltaren Arthritis Pain was based on the clinical data in hand and knee OA supporting the original prescription approval. The data showed consistent relief in pain, starting as early as the first week.
UCLA rheumatology professor Roy Altman said: “Osteoarthritis treatment guidelines from several international and United States medical societies, including the 2019 American College of Rheumatology (ACR) endorse the early use of topical NSAIDs for treating arthritis pain of the knee and hand. In contrast to prior guidelines, the recommendations are inclusive of all age groups, not just the elderly.”