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Reaction and Significance of SPN-830 Approval for Parkinson Disease: Stuart Isaacson, MD, FAAN
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The director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, discussed SPN-830, the first and only FDA-approved subcutaneous apomorphine infusion device for patients with Parkinson disease. [WATCH TIME: 2 minutes]
WATCH TIME: 2 minutes
"For our patients, we've had a long-felt unmet need...finally, it's been approved by the FDA, and we've had a lot of interest from our patients already in calling about this."
Earlier this month, the FDA approved SPN-830 (Supernus Pharmaceuticals) as the first and only apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson disease (PD). Marketed as Onapgo, the therapy is expected to be made available in the second quarter of 2025, becoming another major option for those living with the neurodegenerative disease.
The therapy's approval was supported by data from the TOLEDO study (NCT02006121), a randomized, double-blind trial. In this study, treatment with the device resulted in a reduction of 1.89 hours per day of OFF time for Parkinson's disease patients compared to a placebo. Published in Lancet Neurology in 2018, the study enrolled 106 patients, who were randomly assigned to receive either a 3-mg/hour to 8-mg/hour dose of apomorphine (n = 53) or a placebo saline infusion (n = 53) during waking hours over a 12-week period.
To understand more about the significance of this approval, NeurologyLive® reached out to movement disorders expert Stuart Isaacson, MD, director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida. In this episode, Isaacson shared his initial reaction to the approval and what it means for those in the PD community, noting that it represents a “breakthrough” for individuals who experience OFF times between doses of levodopa. He also noted that the approval is particularly significant for the U.S., where such a treatment has been unavailable, despite its use in Europe for decades.
