Hyloris Pharma receives FDA approval to treat pain


(Reuters) – The U.S. health regulator has approved Heloris for the treatment of post-surgical 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 medication, branded Maxigesic IV, is approved as a post-surgery medication in hospitals or when patients cannot take the medication orally.

Maxigesic IV, a combination of paracetamol and ibuprofen solution for infusion, helps reduce pain and inflammation without the risk of opioid addiction that killed more than half a million in the United States from 1999 to 2020.

The US Food and Drug Administration’s decision was based on data from a recent study that showed the drug was more effective in relieving pain than commonly used intravenous paracetamol.

Stijn van Rompuy, the company’s CEO, said in an interview with Reuters that the company’s injectable drug is significantly superior to its competitor paracetamol, which is the most widely used pain treatment in the United States along with ketorolac.

The company said in an email to Reuters that the price of the drug will be determined by Hikma Pharmaceuticals, which will market it commercially in the United States.

Maxigesic IV was developed in partnership with New Zealand pharmaceutical company AFT Pharmaceuticals.

Hyloris said after the first US sales that it expects to receive a payment of up to $3.5 million related to milestones, among other things.

Vertex Pharmaceuticals’ VX-548, which recently succeeded in a mid-stage trial, is likely to be another non-opioid treatment option for postoperative surgery on its way to the market.

(Reporting by Sriparna Roy and Khushi Mandwara in Bengaluru; Editing by Tsim Zahid and Shailesh Kuber)

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