FDA Approves Maxigesic® IV to be Marketed in the U.S. as Combogesic® IV (acetaminophen and ibuprofen) for the Management of Pain
October 18, 2023 – Hyloris Pharmaceuticals SA), today announced Maxigesic® IV has been approved for the relief of mild to moderate pain and for the management of moderate to severe pain as an adjunct to opioid analgesics in adults, where an intravenous route of administration is considered clinically necessary.
The approval for the New Drug Application (NDA) is based on positive data from a Phase 3 program in which Maxigesic® IV demonstrated that it was well tolerated and offered faster onset of action and higher pain relief compared to Paracetamol IV (Acetaminophen IV) and Ibuprofen IV, as well as placebo. The superior analgesic effect of Maxigesic® IV was also supported by a range of secondary endpoints, including reduced opioid usage rates.
Distribution of Combogesic® IV in U.S. hospitals should start in early 2024.
