SPN-830, now Onapgo, FDA approved for advanced Parkinson’s disease

The U.S. Food and Drug Administration (FDA) has approved Onapgo (apomorphine hydrochloride) as an under-the-skin infusion device for continuous treatment of motor fluctuations in adults with advanced Parkinson’s disease. Developed by Supernus Pharmaceuticals, this approval followed three previous unsuccessful attempts due to FDA concerns about quality, manufacturing, and device performance. Onapgo will be available in the second quarter of 2025, accompanied by a support system including nurse education and access resources. Onapgo is a portable electronic pump that delivers apomorphine continuously for 14–18 hours daily via a subcutaneous infusion. This approach offers more consistent symptom control by bypassing the gastrointestinal tract, avoiding the variable absorption issues that oral medications like levodopa face. Apomorphine mimics dopamine’s activity in the brain, helping to reduce off periods—times when motor symptoms worsen between medication doses. This makes Onapgo a less invasive alternative to injection-based treatments like Apokyn, which is already approved for on-demand use during off episodes. The approval is based on results from the TOLEDO Phase 3 clinical trial, which demonstrated reduced off time and improved on time (when symptoms are controlled) in patients experiencing multiple daily hours of motor fluctuations despite levodopa treatment. Parkinson’s experts and patient advocates highlight that consistent symptom control with devices like Onapgo can help make life more predictable for patients as Parkinson’s progresses. Supernus faced a long road to approval, with earlier rejections from the FDA in 2020, 2021, and 2023 due to various concerns. Continuous apomorphine infusion has been available in Europe for decades, and Onapgo now provides U.S. patients with a lightweight, wearable device offering similar benefits without requiring surgery. Common side effects of Onapgo include infusion site reactions, nausea, drowsiness, headaches, insomnia, and involuntary movements (dyskinesia).