FDA approves GSK’s Advil Dual Action with Acetaminophen OTC pain reliever

GlaxoSmithKline (GSK) has secured approval for Advil Dual Action with Acetaminophen from the US Food and Drug Administration (FDA) as an over-the-counter (OTC) product for pain relief.

According to the company, Advil Dual Action with Acetaminophen is now the first OTC combination of ibuprofen and acetaminophen to get approval in the US.

The new product is said to give relief for various symptoms and is the first formulation to combine the two ingredients indicated for OTC pain relief that have different mechanisms.

Ibuprofen is a nonsteroidal anti-inflammatory (NSAID), which is designed to target pain at the source. It is known for temporarily lowering the production of prostaglandins, which lead to swelling and pain signals.

Acetaminophen is a pain reliever that prevents the transmission of pain signals to the brain.

GSK plans to launch Advil Dual Action with Acetaminophen across the country this year.

The FDA approval for the new pain relief product is based on the findings of seven clinical studies. Three of them were pivotal efficacy and safety studies in pain relief.

GSK said that the data from the studies supports a pain relief indication and shows that the fixed-dose combination delivered superior efficacy when compared to the individual monocomponents of 250mg ibuprofen and 500mg acetaminophen alone.

The superior efficacy was proven by appreciable improvements in acute pain symptoms across various pre-specified endpoints, said GSK.

GSK consumer healthcare R&D head Franck Riot said: "For decades, many consumers have been using ibuprofen and acetaminophen to get the benefits of both active ingredients when safely treating their headaches, muscle aches, backaches, arthritis and other joint pain.

"Now Advil, the No. 1 selling OTC pain reliever, will offer US consumers the first-ever alternative option — a single, fixed-dose combination pain reliever. As the world-leader in pain relief, Advil Dual Action and our recently FDA-approved Voltaren Arthritis Pain gel, demonstrates GSK’s commitment to providing new safe, effective and convenient pain relief options for consumers."

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