Warren, US --
Franck Riot, Head of R&D,
Advil Dual Action provides relief for multiple symptoms and is the first formulation that combines ibuprofen and acetaminophen, two powerful ingredients indicated for OTC pain relief that work in different ways.
The submission in support of today's approval of Advil Dual Action was based on data from seven clinical studies, three of which were pivotal efficacy and safety studies in pain relief. The data supports a pain relief indication and demonstrates that the fixed-dose combination achieves superior efficacy compared to the individual monocomponents of ibuprofen (250mg) and acetaminophen (500mg) alone (as evidenced by appreciable improvements in acute pain symptoms across multiple pre-specified endpoints).
About Advil Dual Action
Advil Dual Action is an exclusive pain-fighting formula, combining ibuprofen and acetaminophen to fight pain in two ways. Ibuprofen is a nonsteroidal anti-inflammatory (NSAID) that targets pain at the source, temporarily reducing the production of prostaglandins, which cause swelling and pain signals. Acetaminophen is a pain reliever that blocks the transmission of pain signals to the brain. Advil Dual Action will be available over-the-counter nationwide in 2020.
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
Important safety information about Advil Dual Action
Before using the product, consumers should read the Advil Dual Action drug facts label.
About GSK
We are 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-us.
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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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