Hyloris Pharma wins US FDA approval for pain treatment
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[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.
![](http://archives.lincolndailynews.com/2023/Oct/18/images/ads/current/charrons_bch_2022.png)
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.
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![](../images/101823PIX/health30.jpg)
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
![](http://archives.lincolndailynews.com/2023/Oct/18/images/ads/current/businessdirectory_dailycover_2023.png) 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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