Safety Considerations and Personalizing SPN-830 Treatment for Parkinson Disease: Stuart Isaacson, MD, FAAN

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"On average, most patients are about half of their waking day with benefit from levodopa... with apomorphine, they then have about three quarters of their day good on time."

Drug development for Parkinson disease (PD) has ramped up in recent years, with the FDA’s latest approval, a new subcutaneous apomorphine infusion device, coming in early February. SPN-830 (Supernus Pharmaceuticals), marketed as Onapgo, was approved based on data from the TOLEDO study (NCT02006121), a randomized, double-blind study of 106 patients with the disease who were assigned to either 3-mg/hr to 8-mg/hr dose of apomorphine (n = 53) or placebo saline during wake hours for a 12-week period.

Apomorphine was first approved in 2004 under the brand name Apokyn for the acute, intermittent treatment of OFF episodes in PD. Apokyn is different from SPN-830, as it is administered by subcutaneous injection with a multiple-dose pen injector that can be used up to 5 times a day, with doses no less than 2 hours apart. In TOLEDO, SPN-830 was generally well tolerated, with adverse events (AEs) that were mild or moderate. Treatment-emergent AEs were reported in 93% of patients on SPN-830 vs 57% of those on placebo, with common AEs including skin reactions, nausea, and somnolence.

In a recent conversation, movement disorders expert Stuart Isaacson, MD, FAAN, discussed SPN-830 as a new treatment for PD, emphasizing its safety and effectiveness. He highlighted the importance of titrating the drug slowly to avoid common side effects like nausea or orthostatic lightheadedness. Based on extensive European and recent U.S. data, he reassured clinicians that SPN-830 has shown a long safety profile and can be safely incorporated into clinical practice for patients with inconsistent responses to oral levodopa. Furthermore, Isaacson also mentioned that SPN-830 may be an ideal therapy for patients experiencing unpredictable OFF times despite other treatments.

REFERENCES
1. Supernus Announces FDA Approval of ONAPGO™ (apomorphine hydrochloride) for Parkinson’s Disease. News Release. Supernus. Published February 10, 2025. Accessed February 5, 2025. https://ir.supernus.com/news-releases/news-release-details/supernus-announces-fda-approval-onapgotm-apomorphine
2. Katzenschlager R, Poewe W, Rascol O, et al. Apomorphine subcutaneous infusion in patients with Parkinson's disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomized, placebo-controlled trial. Lancet Neurol. 2018;17(9):749-759. doi:10.1016/S1474-4422(18)30239-4