FDA
Apomorphine infusion device OK’d for Parkinson’s disease
Brand name: Onapgo
Generic name: apomorphine HCl
Manufacturer: Supernus Pharmaceuticals
Approval date: February 4, 2025
FDA approved Onapgo (apomorphine HCl) injection, a non-ergoline dopamine agonist formerly known as SPN-830, as the first SC apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson disease (PD).
According to the manufacturer, Onapgo will be available in the second quarter of 2025.
Efficacy
Approval was based on data from the phase 3 TOLEDO trial (NCT02006121) involving 107 participants with advanced PD. The primary efficacy endpoint was the mean change in total daily “off” time assessed from baseline to the end of the 12-week treatment period based on patient diaries. The key secondary endpoints were the mean change in daily “good on” time, defined as “on” time without troublesome dyskinesia, and Patient Global Impression of Change (PGIC).
Onapgo significantly reduced the amount of daily “off” time at 12 weeks from baseline (p = 0.0114), with Onapgo recipients (n = 53) experiencing a 2.6-hour reduction compared with 0.9 hours in the placebo group (n = 51). Reduction in daily “off” time was accompanied by a similar increase in daily “good on” time (2.8 hours for Onapgo recipients vs. 1.1 hours for the placebo group; p = 0.0188). Numerically greater improvements in daily “off” time and daily “good on” were seen as early as week 1 and were maintained throughout all measured timepoints. Onapgo-treated patients more frequently reported improvement in their state of general health compared with placebo-treated patients (PGIC: 79% vs. 24%; p < 0.0001).
Safety
The most common adverse events (≥ 10%) were infusion-site nodule, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia.
Sources:
Supernus announces FDA approval of Onapgo™ (apomorphine hydrochloride) for Parkinson’s disease. Supernus Pharmaceuticals. 2025. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-onapgotm-apomorphine
Onapgo. Package insert. Supernus Pharmaceuticals. 2025. https://www.onapgo.com/onapgo_PI.pdf