The Food and Drug Administration (FDA) has accepted the New Drug Application for Maxigesic® IV (acetaminophen and ibuprofen solution for infusion) for the treatment of postoperative pain.
Maxigesic is a combination of acetaminophen 1000mg and ibuprofen 300mg for intravenous (IV) infusion. The application is supported by data from two phase 3 studies (ClinicalTrials.gov Identifier: NCT02689063 and NCT04005755) evaluating the effects of Maxigesic in adults with postoperative pain. In the first study, 276 patients with acute postoperative pain following bunionectomy surgery were randomly assigned to receive IV infusions of Maxigesic 1000mg/300mg, acetaminophen 1000mg, ibuprofen 300mg, or placebo.
Results showed a faster onset of action and greater pain relief with Maxigesic compared with ibuprofen IV or acetaminophen IV alone. Treatment with Maxigesic was also associated with superior analgesic effects across secondary endpoints, including reduced opioid usage rates when compared with acetaminophen, ibuprofen, and placebo (P <.005).
The second safety study included 232 patients undergoing general, orthopedic, or plastic surgery. Patients received Maxigesic IV 1000mg/300mg every 6 hours for a minimum of 48 hours up to at least 5 days. Findings showed the combination therapy was safe and well tolerated.
“Upon approval, Maxigesic IV will be commercialized by Hikma Pharmaceuticals, a leading supplier of complex, injectable hospital products in the US,” said Stijn Van Rompay, Chief Executive Officer of Hyloris. According to the Company, the Prescription Drug User Fee Act target date is estimated to be between August and September 2022.
Hyloris announces FDA acceptance of New Drug Application for Maxigesic® IV in post-operative pain. News release. Hyloris Pharmaceuticals SA. Accessed November 1, 2021. https://www.globenewswire.com/news-release/2021/11/01/2324058/0/en/Hyloris-Announces-FDA-Acceptance-of-New-Drug-Application-for-Maxigesic-IV-in-Post-Operative-Pain.html.