The FDA approved an apomorphine hydrochloride infusion device (Onapgo) to treat motor fluctuations in adults with advanced Parkinson’s disease, Supernus Pharmaceuticals announced on Tuesday.
The wearable device is the first subcutaneous apomorphine infusion device for Parkinson’s and provides continuous treatment during the day, Supernus noted.
“As Parkinson’s disease progresses, levodopa treatment often becomes less effective at delivering consistent motor control in part due to GI dysmotility, variable absorption of oral medication, and the resulting pulsatile stimulation of dopamine pathways in the brain,” said Stuart Isaacson, MD, of the Parkinson’s Disease and Movement Disorders Center of Boca Raton in Florida and a clinical trial investigator for the device.
“With Onapgo, the continuous infusion of apomorphine directly stimulates postsynaptic dopamine receptors with no metabolic conversion needed,” Isaacson continued. “In addition, the subcutaneous delivery of apomorphine bypasses the GI tract and enters the brain, which can allow for more predictable symptom improvement.”
The approval comes nearly a year after the FDA rejected the device for the second time. In August 2024, Supernus resubmitted a new drug application for the drug-device combination.
The FDA’s decision was supported by the phase III TOLEDO trial of 107 Parkinson’s patients with persistent motor fluctuations in Europe that showed apomorphine infusion had clinically meaningful effects on off time.
In the double-blind phase of TOLEDO, apomorphine infusion reduced off time (-2.47 hours/day in the apomorphine group vs -0.58 hours/day in the placebo group; difference -1.89 hours/day, 95% CI -3.16 to -0.62, P=0.0025) at a mean final dose of 4.68 mg/hour.
The treatment also increased on time without troublesome dyskinesia compared with placebo. Apomorphine infusion was well tolerated without unexpected safety signals.
Six patients, all in the apomorphine group in TOLEDO, had an adverse event that led to study withdrawal. Three people withdrew because of serious adverse events: one had severe hypotension, one had myocardial infarction, and one had persistently abnormal hematology test results indicating mild leucopenia and moderate anemia.
Besides those three patients, two others in the apomorphine group had serious adverse events, including one case of severe intermittent confusion (resolved with dose reduction) and one case of severe infusion-site cellulitis (which also was resolved).
The most common adverse events (incidence of 10% or more) with the device include infusion-site nodules, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia, Supernus reported.
The company said it plans to make the treatment available in the second quarter of 2025.
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