FDA Approves Continuous Sub-Q Tx for Parkinson’s – Onapgo

Following what seems to be a new trend, the FDA has approved yet another 20+ year old therapy based on a major remodel… this one was originally approved in 2004. 

The therapy in question is Onapgo (apomorphine hydrochloride) injection from Supernus Pharmaceuticals, now available for subcutaneous use indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. 

Onapgo is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.  Onapgo is a wearable subcutaneous infusion device that provides continuous treatment during the waking day for more consistent control of ‘OFF’ time. Onapgo is the second under-the-skin infusion-based therapy approved by the FDA this year for Parkinson’s, the first being Vyalev which delivers a continuous infusion of levodopa and carbidopa. Onapgo is a dopamine agonist that acts like dopamine, the brain chemical that affects movement and decreases in people with Parkinson’s. By dosing continuously sub-q, Onapgo bypasses the gastrointestinal (GI) tract allowing improved dosing direct to the brain.

Supernus expects to launch Onapgo in Q2-2025. As noted in an article, one analyst expects pricing to be in line with Vyalev and launch with a WAC of ~$119,000 for a year of therapy

The company did not release any details related to distribution.

CLICK HERE to access prescribing information

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Second Under-the-Skin Infusion for Parkinson’s Earns FDA Approval

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