FDA Approves First OTC Acetaminophen-Ibuprofen Combination

The US Food and Drug Administration (FDA) has approved the first dual-action over-the-counter (OTC) combination of ibuprofen and acetaminophen in the US.

GlaxoSmithKline’s (GSK) Advil Dual Action with Acetaminophen was approved as an OTC pain relief combination therapy Friday, supported by data from 7 clinical trials. In 3 such trials, the drug showed pivotal efficacy and safety outcomes in assessment for patient pain relief.

The clinical trial data, according to GSK, supports the pain relief indication, and demonstrates superior efficacy of fixed-dose combination ibuprofen plus acetaminophen when compared to lone 250 mg ibuprofen or 500 mg acetaminophen, when assessing for improvements in acute pain symptoms across multiple pre-specified endpoints.

Ibuprofen is a nonsteroidal anti-inflammatory drug that temporarily reduces the production of prostaglandins, which are responsible for signaling for swelling and pain. Acetaminophen is a pain reliever shown to block the transmission of pain signals to the brain.

Franck Riot, head of R&D for GSK Consumer Healthcare, noted the 2 individual therapies have been used by consumers for decades for widely varying instances of pain: 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,” Riot said in a statement. “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."

GSK announced the combination therapy will be available as an OTC option nationwide this year.