FDA Approves Onapgo: Breakthrough Infusion Device for Advanced Parkinson’s Disease
The FDA approved Onapgo (apomorphine hydrochloride) on February 4, 2025, for the treatment of motor fluctuations in adults with advanced Parkinson's disease13.
Onapgo is the first and only FDA-approved subcutaneous apomorphine infusion device for Parkinson's disease in the United States78.
The device delivers continuous infusion of apomorphine, a non-ergoline dopamine agonist, to reduce "off" episodes in Parkinson's patients14.
In clinical trials, Onapgo reduced daily "off" time by nearly two hours compared to placebo34.
The approval was based on the phase 3 TOLEDO study, which included 107 adults with Parkinson's disease13.
Onapgo is expected to be available in the U.S. market in the second quarter of 202578.
The device offers a non-surgical alternative for continuous symptom management, bypassing the gastrointestinal tract for more predictable symptom improvement14.
Common side effects include headache, nausea, daytime sleepiness, and injection site reactions3.
Onapgo represents Supernus Pharmaceuticals' fourth attempt at FDA approval, following previous rejections and requests for additional data27.
The approval of Onapgo adds to the growing list of treatment options for Parkinson's disease, with over 20 treatments approved since 20153.
Sources:
1. https://www.empr.com/news/apomorphine-infusion-device-onapgo-approved-for-parkinson-disease/
2. https://www.fiercepharma.com/pharma/watchdog-recommends-tweaks-fda-accelerated-approval-program
3. https://www.michaeljfox.org/news/second-under-skin-infusion-parkinsons-earns-fda-approval
4. https://newatlas.com/medical-devices/parkinsons-disease-onapgo/
7. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-onapgotm-apomorphine
8. https://www.ajmc.com/view/fda-approves-first-subcutaneous-apomorphine-device-for-parkinson-disease