FDA Approves New Wearable Treatment for Parkinson Disease

©Argus/AdobeStock

The US FDA has approved an apomorphine hydrochloride infusion device (Onapgo™), the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson disease, Supernus Pharmaceuticals announced on Tuesday.¹

"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," 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, said in a press release.¹

"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."¹

The approval comes nearly a year after the FDA rejected the device for the second time.² In August 2024, Supernus resubmitted a new drug application for the drug-device combination.³

The FDA's decision was supported by the phase III TOLEDO trial of 107 individuals with Parkinson disease with persistent motor fluctuations in Europe that showed apomorphine infusion had clinically meaningful effects on off time—a period when standard medications for Parkinson disease lose effectiveness.¹

Results also showed that apomorphine infusion significantly reduced daily off time by 2.6 hours compared to 0.9 hours with placebo (P = .0114). It also increased daily “good on” time—when symptoms are well controlled—by 2.8 hours compared to 1.1 hours in the placebo group (P = .0188). Furthermore, researchers observed numerically greater improvements in daily off time and good on time as early as week 1, which were maintained throughout all measured timepoints, according to the release.¹

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.¹

The device is expected to be available in the US by the second quarter of 2025, accompanied by a dedicated support program including nurse education and access assistance.¹

“Today’s approval of ONAPGO means patients in the U.S. who are not responding well to their current treatment regimen, including levodopa, will now have the option of using a small and lightweight wearable device to deliver a continuous infusion without the need for an invasive surgical procedure,” Rajesh Pahwa, MD, the Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, and a clinical trial investigator for the device, said in the release.¹