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
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SOURCE GlaxoSmithKline