U.S. FDA approves Supernus' drug-device combination for Parkinson's disease (updated)

Supernus Pharmaceuticals

04/02/2025 14:30

(Adds details on launch in paragraph 2, background in
paragraphs 3 and 4)
       Feb 4 (Reuters) - The U.S. Food and Drug Administration
has approved Supernus Pharmaceuticals'  SUPN.O  drug-device
combination to treat movement-related symptoms of Parkinson's
disease, the drugmaker said on Tuesday.
    The treatment branded Onapgo will be available in the U.S.
in the second quarter.
    The drug regulator's greenlight brings an end in the
company's years-long effort to market the pump-based treatment,
which works by continuously delivering the drug apomorphine
under-the-skin, compared with the currently approved injection
form which has to be given as often as two hours apart.
    The FDA declined to approve Supernus' application in 2022
and 2024, with the regulator last year requesting additional
information related to product quality and the device.
    

 (Reporting by Puyaan Singh in Bengaluru; Editing by Leroy Leo)
 ((Puyaan.Singh@thomsonreuters.com))