Hyloris Pharma wins US FDA approval for pain treatment

Hyloris Pharmaceuticals SA

18/10/2023 06:00

Oct 18 (Reuters) - The U.S. health regulator has
approved Hyloris Pharmaceuticals'  HYL.BR  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  HIK.L , which
will commercialize it in the United States.
    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'  VRTX.O  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)
 ((Sriparna.Roy@thomsonreuters.com;))