Onapgo FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 12, 2025.
FDA Approved: Yes (First approved February 3, 2025)
Brand name: Onapgo
Generic name: apomorphine hydrochloride
Dosage form: Subcutaneous Infusion Device
Previous Name: SPN-830
Company: Supernus Pharmaceuticals, Inc.
Treatment for: Parkinson's Disease
Onapgo (apomorphine hydrochloride) is a continuous subcutaneous infusion formulation of the approved dopaminergic agonist apomorphine for the treatment of motor fluctuations (OFF episodes) in adults with advanced Parkinson’s disease.
- OFF episodes in patients with Parkinson’s disease are periods of hypomobility that result from low levels of dopamine between scheduled doses of levodopa. OFF episodes can become more unpredictable as Parkinson’s disease progresses to the advanced stages.
- Onapgo contains apomorphine, which works as a dopamine agonist that binds with high affinity to the dopamine D4 receptor, and moderate affinity to the dopamine D2, D3, and D5, and adrenergic α1D, α2B, α2C receptors. The way in which apomorphine works as a treatment for Parkinson’s disease is believed to be due to stimulation of post-synaptic dopamine D2-type receptors within the caudate-putamen in the brain.
- Apomorphine was first approved in 2004 under the brand name Apokyn for the acute, intermittent treatment of OFF episodes in Parkinson’s disease. Apokyn is administered by subcutaneous injection with a multiple-dose pen injector that can be used up to five times a day, with doses no less than two hours apart. Onapgo is designed to provide more consistent control of OFF episodes by delivering apomorphine continuously during the waking day through a subcutaneous infusion device.
- FDA approval of Onapgo was based on the results from a Phase 3, double-blind, randomized, placebo-controlled study (N=107) that demonstrated that Onapgo significantly reduced the amount of daily OFF time at 12 weeks from baseline (p=0.0114), with Onapgo-treated patients (n=53) experiencing a 2.6-hour reduction compared to placebo (n=51) with 0.9 hours. The reduction in daily OFF time was accompanied by a similar significant increase in daily GOOD ON time (2.8 hours for Onapgo-treated patients compared to 1.1 hours for the placebo group; p=0.0188).
- Onapgo is administered by continuous subcutaneous infusion via delivery device for up to 16 hours during the waking day. Premedication with trimethobenzamide is recommended prior to starting Onapgo treatment to control nausea and vomiting.
- Warnings and precautions associated with Onapgo include nausea and vomiting, falling asleep during activities of daily living and daytime somnolence, hypotension/orthostatic hypotension and syncope, increased risk of falls, infusion site reactions and infections, hallucinations and psychotic-like behavior, dyskinesia or exacerbation of pre-existing dyskinesia, hemolytic anemia, impulse control/ compulsive and impulsive behaviors, cardiac events, and QTc prolongation.
- Common adverse reactions include infusion site nodule, nausea, somnolence, infusion site erythema, dyskinesia, headache, and insomnia.
Development timeline for Onapgo
Further information
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