The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' 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.