Feb 17, 2020: GlaxoSmithKline announced that the U.S.FDA has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the wrist, elbow, hand, foot, ankle or knee in adults (18 years and older).
After the FDA’s approval, Voltaren Arthritis Pain becomes the first and the only prescription-strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain accessible OTC in the United States.
“Voltaren Gel, to whom GSKCH has the rights, is currently available in the US only with a prescription. Voltaren Arthritis Pain’s OTC approval today will provide over – the counter access to this topical treatment option for the nearly 30 million Americans with osteoarthritis.
Franck Riot, Head of R&D, GSK Consumer Healthcare said: “For the millions of the people around the world living with arthritis, joint pain and stiffness are everyday realities. At GSK, we are committed to getting better the quality of life of these people and today’s approval is progress towards this, providing consumers in the US with increased right to use an effective, proven arthritis pain relief option.
At present Voltaren is the number 1- OTC topical pain relief brand globally, and we look forward to expanding its accessibility in the US.”
Additionally, the Osteoarthritis Research Society International (OARSI) just updated and expanded their new guidelines for non-surgical management of OA by developing patient-focused treatment recommendations. These updated guidelines powerfully recommend topical non-steroidal anti-inflammatory drugs (NSAIDs) for persons with knee OA. Of the non-core interventions measured as part of this guideline update, topical NSAIDs were suggested more strongly than all oral analgesics due to favourable balance of consistent effectiveness and minor transient side effects. The submission in support of the Voltaren Arthritis Pain approval today was based on clinical evidence in hand and knee OA supporting the initial drug approval. The data showed a clear and appreciable progression of pain relief starting as early as week 1 (as demonstrated by significant pain symptom changes across multiple pre-specified endpoints).
About Voltaren Arthritis Pain: The active ingredient in Voltaren Arthritis Pain, diclofenac sodium, is an effective medicine that is clinically proven in order to relieve joint pain due to arthritis. Voltaren Arthritis Pain penetrates through the skin at the application site in order to deliver arthritis pain relief. Voltaren Arthritis Pain offers patient who suffers from OA a different option to oral analgesics. It targets pain directly at the site and amount of the diclofenac sodium that is systemically absorbed from the Voltaren Arthritis Pain is on average 6% of the systemic exposure from an oral form of the diclofenac sodium. GSK anticipates Voltaren Arthritis Pain will be accessible on US shelves in Spring 2020”. For more information, visit www.VoltarenGel.com.
https://us.gsk.com/en-us/media/press-releases/fda-approves-gsk-s-voltaren-arthritis-pain-for-over-the-counter-use-in-the-united-states/
