United States: The U.S. Food and Drug Administration approved Onapgo (apomorphine hydrochloride) injection as a subcutaneous apomorphine infusion device for managing motor fluctuations in advanced Parkinson’s disease patients through its news release from Supernus Pharmaceuticals, as reported by HealthDay.
Availability and Patient Support Program
The Onapgo device stands as the first wearable subcutaneous apomorphine infusion device that gives patients long-lasting treatment coverage during daytime hours thereby providing better control of motor fluctuations. The upcoming availability of the product is scheduled for the second quarter of 2025. The team which will support the launch consists of professionals who will deliver an extensive nurse education program.
FDA approves Onapgo wearable subcutaneous infusion device for Parkinson disease
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FDA has approved a wearable subcutaneous infusion device to deliver medication throughout the day to adults with advanced Parkinson disease. While the technology been …https://t.co/CF9XqdqGs1 pic.twitter.com/ytQcO5EtXg
Clinical Trial Highlights
A phase 3 clinical trial assessed the effectiveness and security of Onapgo through a 12-week multicenter, double-blind, randomized study that included 107 patients. Subjects taking Onapgo showed better outcomes versus placebo users by cutting their daily OFF time by 2.6 hours compared to 0.9 hours. Patients receiving treatment with Onapgo spent more time in a period of good on effects (2.8 hours versus 1.1 hours per day) and displayed increased OFF time reduction (2.6 hours versus 0.9 hours per day). The initial week of treatment already demonstrated enhanced OFF and GOOD ON duration, which sustained across all time points throughout the study. Infusion-site nodule along with nausea and excessive sleepiness and infusion-site skin irritation were among the most frequently reported adverse symptoms (higher than 10 percent incidence) along with headache and insomnia, as reported by HealthDay.
Addressing ON-OFF Fluctuations
“As the motor symptoms of Parkinson’s disease worsen over time, patients report alternating states between ON when their medication is working, and OFF when it’s not working optimally,” Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance in Phoenix, said in a statement. “These on-again, off-again changes are disruptive and can happen at any time, which is why consistent daily control of OFF time is key to improving how patients feel and move. For many, continuous treatment options like Onapgo can help to make days with Parkinson’s more predictable.”