FDA approves GSK's Voltaren Arthritis Pain for over-the-counter use in the United States

WARREN, N.J., Feb. 17, 2020 /PRNewswire/ -- GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (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 hand, wrist, elbow, foot, ankle or knee in adults (18 years and older).  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 osteoarthritisⁱ over-the-counter access to this topical treatment option.  

Franck Riot, Head of R&D, GSK Consumer Healthcare 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."

Dr. Roy Altman, Professor of Medicine in Rheumatology at UCLA 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."

In addition, the Osteoarthritis Research Society International (OARSI) recently updated and expanded their 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 effectsⁱⁱ.

The submission in support of today'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). 

About Voltaren Arthritis Pain
The active ingredient in Voltaren Arthritis Pain, diclofenac sodium, is an effective medicine that is clinically proven to relieve joint pain due to arthritis. Voltaren Arthritis Pain penetrates through the skin at the application site to deliver arthritis pain relief. Voltaren Arthritis Pain offers consumers who suffer from OA an alternative option to oral analgesics.  It targets pain directly at the site and the amount of diclofenac sodium that is systemically absorbed from Voltaren Arthritis Pain is on average 6% of the systemic exposure from an oral form of diclofenac sodium. GSK anticipates Voltaren Arthritis Pain will be available on US shelves in Spring 2020. For more information, visit www.VoltarenGel.com.

About osteoarthritis
Osteoarthritis (OA) is the most common form of arthritis. OA occurs when the cartilage between joints begins to break down and wear away, resulting in joint pain and stiffness. OA occurs more frequently with age, and the pain can gradually worsen over time. The most common symptoms associated with OA include joint pain, stiffness, and decreased range of motion.

GSK's commitment to pain relief
We are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

Important safety information about Voltaren Arthritis Pain
Before using the product, consumers should read the Voltaren Arthritis Pain Drug Facts Label. 

About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com.

About GSK Consumer Healthcare
We are the world's largest Consumer Healthcare company following our new joint venture with Pfizer Consumer Healthcare. We develop and market a portfolio of consumer-preferred and expert-recommended brands including Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu.

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2018.

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ⁱ Arthritis By The Numbers. Arthritis Foundation. (2018)
Retrieved from https://www.arthritis.org/Documents/Sections/About-Arthritis/arthritis-facts-stats-figures.pdf  

ⁱⁱ OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis
Crossref DOI link: https://doi.org/10.1016/J.JOCA.2019.06.011

SOURCE GlaxoSmithKline

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