Officials with the FDA have approved the first subcutaneous apomorphine infusion (Onapgo; Supernus) for patients with Parkinson’s disease.1
Apomorphine is a dopamine agonist whose effects have a rapid onset. It has been available in the United States as a subcutaneous injection, known as Apokyn, which is used ”as needed” in patients with Parkinson’s disease (PD) whose symptoms are not well controlled. With this approval, the medication is also available via a subcutaneous infusion device, providing continuous treatment of apomorphine during the waking day for more consistent control of PD symptoms and decrease in off time. The apomorphine subcutaneous infusion has been a treatment option for people with PD in Europe for many years.
The therapy’s approval was based on data from the TOLEDO study (NCT02006121), a placebo-controlled, double-blind study of 107 patients with PD whose symptoms were not controlled optimally with oral medication who were randomly assigned to treatment with the subcutaneous apomorphine pump or placebo. Patients who had the pump had close to 2 hours less of off time in a day, compared with patients treated with placebo.
Officials with Supernus noted that the therapy will be available for use in the United States within the next few months. Insurance coverage, including Medicare coverage, will evolve over the next few months as well.
Reference
- Supernus Pharmaceuticals. Supernus announces FDA approval of Onapgo (apomorphine hydrochloride) for Parkinson’s disease [press release]. February 4, 2025. Accessed February 17, 2025. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-onapgotm-apomorphine