Hyloris Pharma wins US FDA approval for pain treatment

[October 18, 2023]  (Reuters) - The U.S. health regulator has approved Hyloris Pharmaceuticals' drug for post-operative pain, the Belgium-based company said on Wednesday, adding that it expects to launch the non-opioid treatment in the United States by early next year.

The injectable drug, branded as Maxigesic IV, was approved as a post-operative drug in hospitals or when patients cannot take medicine orally.

Maxigesic IV, a combination of paracetamol with ibuprofen solution for infusion, helps reduce pain and inflammation without the risk of opioid addiction that resulted in more than half a million deaths in the U.S. during 1999 to 2020.

The U.S. Food and Drug Administration's decision was based on data from a late-stage study that showed the drug to be more effective in relieving pain than commonly-used intravenous paracetamol.

The company's injectable drug is significantly superior to its competition paracetamol, which is the most used pain treatment in the U.S. along with ketorolac, said CEO Stijn Van Rompay in a interview with Reuters.

The company in a mail to Reuters said the pricing of the drug will be determined by Hikma Pharmaceuticals, which will commercialize it in the United States.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

Maxigesic IV has been developed in partnership with New Zealand-based drugmaker AFT Pharmaceuticals.

Hyloris said after the first U.S. sales it expects to receive a payment of up to $3.5 million related to milestones, among others.

Vertex Pharmaceuticals' drug VX-548, which recently succeeded in a mid-stage trial, could potentially be another post-operative non-opioid therapy option on way to the market.

(Reporting by Sriparna Roy and Khushi Mandowara in Bengaluru; Editing by Tasim Zahid and Shailesh Kuber)

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