Healthcare company GlaxoSmithKline (LSE:GSK) (NYSE:GSK) reported on Monday the receipt of US Food and Drug Administration (FDA) approval for the Voltaren Arthritis Pain over-the-counter (OTC) product for the relief of arthritis pain, expected to be available in Spring 2020.
Following the US FDA approval, the company said its Voltaren Arthritis Pain (OTC) (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) becomes the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel for temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older) in the US.
This OTC approval of Voltaren Arthritis Pain will provide the nearly 30m Americans with osteoarthritisi over-the-counter access topical treatment option. Osteoarthritis (OA) is the most common form of arthritis and the pain can gradually worsen over time, said the company.
The US FDA approval of the company's 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 one.
According to the company, the active ingredient in Voltaren Arthritis Pain, diclofenac sodium, is an effective medicine that is clinically proven to relieve joint pain due to arthritis. 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.
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