FDA Approves Non-Opioid Painkiller for Mild-to-Moderate Pain

Earlier this week, Hyloris Pharmaceuticals, a pharmaceutical company headquartered in Belgium, announced the approval of a potent non-opioid painkiller in the United States. The US Food and Drug Administration (FDA) approved the New Drug Application (NDA) for Maxigesic IV to treat mild-to-moderate pain and as an adjunct therapy for moderate to severe pain.

Partnering with AFT Pharmaceuticals, Hyloris developed Maxigesic IV as an alternative to opioid painkillers after surgical procedures. The drug is a postoperative infusion that combines 1,000 mg of paracetamol and 300 mg of ibuprofen in solution.

“Bringing innovation by reformulating existing medicines highlights how Hyloris can improve patient outcomes, specifically by addressing the devastating opioid crisis in the biggest healthcare market in the world,” said Stijn Van Rompay, Chief Executive Officer of Hyloris, in the press release.

According to the press release from Hyloris, phase 3 clinical trials on 276 patients who had bunion surgery. The press release maintains that Maxigesic was well tolerated and worked faster than other pain relievers. In addition, researchers noted that ibuprofen or paracetamol alone did not provide the same magnitude of pain management.

The company also explained that Maxigesic reduced opioid consumption better than the two compounds that comprise it alone.

According to the CDC, 75% of drug overdoses in the US in 2022 involved an opioid. Many cases of opioid use disorder begin with a prescription. The National Institute on Drug Abuse (NIDA), a part of the National Institutes of Health (NIH), notes that 21–29% of individuals prescribed an opioid for pain management will abuse it.

Furthermore, according to the Hyloris press release, it is estimated that the incidence of new chronic opioid use following surgical procedures in the United States is 6%.

Amidst the opioid pandemic, finding non-opioid pain management alternatives has been paramount for providers and public health experts. Having more of these drugs approved offers more options to minimize the risk of addiction. 

Currently, the product is approved in 40 countries and is expected to enter the US market in 2024 under the trade name Combogesic IV under patent protections until 2038.