FDA Greenlights New Wearable Treatment for Parkinson Disease: Daily Dose

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On February 6, 2025, we reported on the US FDA approval of an apomorphine hydrochloride infusion device (Onapgo™) for the treatment of motor fluctuations in adults with advanced Parkinson disease.

The approval

Onapgo is the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson disease.

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. 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.

The most common adverse events with the device included infusion-site nodules, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia.

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