Hyloris Pharma Secures FDA Approval for Pain Treatment

India Pharma Outlook Team | Thursday, 19 October 2023

 India Pharma Outlook Team

The United States Food and medicine Administration has approved Hyloris Pharmaceuticals' (HYL.BR) medicine for post-operative pain, the Belgian firm said and, adding that the non-opioid treatment will be available in the United States by early next year. The injectable drug, Maxigesic IV, was licensed for use as a post-operative treatment in hospitals or when patients are unable to take medicine orally. Maxigesic IV, an infusion of paracetamol and ibuprofen solution, helps decrease pain and inflammation without the danger of opioid addiction, which resulted in more than 500,000 deaths in the United States from 1999 to 2020.

The decision was based on results from a late-stage study that showed the medicine was more successful in reducing pain than frequently used intravenous paracetamol, as per reuters. The company's injectable medicine is much superior to its competition paracetamol, which is the most often used pain treatment in the United States, along with ketorolac. The company stated that the drug's pricing will be chosen by Hikma Pharmaceuticals (HIK.L), which will sell it in the United States. Maxigesic IV was created in collaboration with AFT Pharmaceuticals of New Zealand. Hyloris plans to collect up to $3.5 million in milestone payments following the first U.S. sales, among other things. VX-548, a medication developed by Vertex Pharmaceuticals (VRTX.O) that just completed a mid-stage trial, could be another post-operative non-opioid therapeutic option in the horizon.

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