Commentary
Video
Reducing OFF Time in Parkinson Disease With SPN-830 Infusion Therapy: Julie Pilitsis, MD, PhD, MBA
The chair of neurosurgery at the University of Arizona talked about the newly approved infusion therapy that offers continuous medication delivery to improve both motor and non-motor symptoms in Parkinson disease. [WATCH TIME: 5 minutes]
WATCH TIME: 5 minutes
"The fact that this therapy reduces those periods of 'OFF' time is significant and has a real impact on patients."
Parkinson disease (PD) is marked by the progressive degeneration of the substantia nigra, resulting in striatal dopamine deficiency and the emergence of motor symptoms. Although dopamine replacement therapy has demonstrated effectiveness, most patients eventually experience motor fluctuations that necessitate treatment adjustments. Deep brain stimulation and continuous dopaminergic drug delivery are viable options for managing these complications, though both involve invasive procedures. Apomorphine, a potent dopamine agonist approved for severe motor fluctuations, has been shown to significantly reduce "OFF" time and levodopa dependence in observational studies. However, until recently, its efficacy had not been confirmed through randomized controlled trials.
To address this gap, the FDA recently approved SPN-830 (Onapgo; Supernus Pharmaceuticals), a subcutaneous apomorphine infusion device, for managing motor fluctuations in adults with advanced PD. Marketed as Onapgo, the drug’s approval was based on findings from the TOLEDO study (NCT02006121), a randomized, double-blind trial that demonstrated a reduction of 1.89 hours per day in "OFF" time compared with placebo.1 Published in The Lancet Neurology, the study enrolled 106 patients, with 53 receiving apomorphine at doses ranging from 3 mg/hour to 8 mg/hour and 53 receiving a placebo saline infusion during wake hours over a 12-week period.2 To discuss the clinical impact of this newly approved therapy, NeurologyLive® spoke with Julie Pilitsis, MD, PhD, MBA, chair of the department of neurosurgery at the University of Arizona and the physician executive for functional neurosurgery for Banner Health.
In discussing the impact of this newly approved therapy, Pilitsis highlighted how continuous subcutaneous apomorphine infusion could shift the standard approach to managing PD by providing a more stable and predictable treatment option. Unlike traditional oral medications, which require time to reach therapeutic levels and often lead to fluctuating symptom control, this infusion maintains a steady state of dopamine stimulation. However, she emphasized that treatment decisions should be individualized, considering factors such as a patient’s tolerance for device-related challenges, potential adverse effects, and response to other available therapies. Although deep brain stimulation and focused ultrasound remain effective surgical alternatives, he noted how this infusion therapy offers a less invasive option for those seeking symptom stability without undergoing a procedure.
REFERENCES
1. Supernus Announces FDA Approval of ONAPGO™ (apomorphine hydrochloride) for Parkinson’s Disease. News Release. Supernus. Published February 4, 2025. Accessed February 4, 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
