The U.S. Food and Drug Administration (FDA) has granted approval to Onapgo (apomorphine hydrochloride) injection, marking it as the first and only subcutaneous apomorphine infusion device designed to treat motor fluctuations in patients with advanced Parkinson’s disease. This groundbreaking approval, announced by Supernus Pharmaceuticals, offers a new therapeutic option for those struggling with the unpredictable symptoms of the progressive neurological disorder.
Onapgo is a wearable device that delivers continuous apomorphine infusion throughout the waking hours, providing patients with more consistent control over motor fluctuations. The treatment is expected to become available in the second quarter of 2025, and will be supported by an extensive educational program aimed at healthcare providers, including a dedicated nurse education team.
The safety and efficacy of Onapgo were evaluated in a Phase 3, 12-week, multicenter, randomized, placebo-controlled study involving 107 participants. Results revealed that patients using Onapgo experienced a significant reduction in daily “OFF” time, with a decrease of 2.6 hours compared to just 0.9 hours in the placebo group. Additionally, those treated with Onapgo saw a notable increase in “GOOD ON” time—time when patients are able to move without difficulty—rising by 2.8 hours compared to 1.1 hours for those on placebo. These improvements were observed as early as the first week of treatment and persisted through the study duration.
Common adverse events (occurring in more than 10% of participants) included infusion-site nodule, nausea, excessive sleepiness, skin irritation, headache, and insomnia. Despite these side effects, Onapgo’s potential to provide better symptom control marks a significant advancement in Parkinson’s disease management.
Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance in Phoenix, emphasized the importance of consistent symptom control, particularly as Parkinson’s disease progresses. “As the motor symptoms of Parkinson’s disease worsen over time, patients experience alternating states of ‘ON’ when their medication works and ‘OFF’ when it doesn’t,” Merriam said. “These unpredictable fluctuations can be disruptive, and continuous treatment options like Onapgo can help stabilize patients’ days, improving both their mobility and quality of life.”
Onapgo’s approval by the FDA represents a promising step forward for those battling advanced Parkinson’s disease, providing a new tool for managing the challenging and often unpredictable motor symptoms associated with the condition.
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