GlaxoSmithKline announced that the U.S. Food and Drug Administration (FDA) has approved Advil Dual Action with Acetaminophen as an over-the-counter (OTC) product for pain relief. The exclusive formula is now the first FDA-approved OTC combination of ibuprofen and acetaminophen in the United States and will be available over-the-counter nationwide in 2020.
Franck Riot, Head of R&D, GSK Consumer Healthcare 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.”
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).