FDA Approves Supernus Pharmaceuticals’ Onapgo for Parkinson’s Disease Treatment

The U.S. Food and Drug Administration (FDA) has approved Supernus Pharmaceuticals’ drug-device combination, Onapgo, for the treatment of movement-related symptoms in Parkinson’s disease. Onapgo, which delivers the drug apomorphine continuously under the skin, provides a more convenient alternative to current injectable treatments that need to be administered as frequently as every two hours.

This approval marks a significant milestone for Supernus, ending a years-long effort to secure FDA approval. The agency had previously rejected the company’s application in 2022 and 2024, requesting additional information related to product quality and the device. The combination therapy, acquired by Supernus in a $530-million deal in 2020, aims to help reduce “off episodes,” where Parkinson’s patients experience an exacerbation of symptoms as their medication wears off.

Onapgo is expected to be available in the U.S. by the second quarter of this year.