FDA Approves Wearable Infusion Device for Advanced Parkinson Disease

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Medically reviewed by Drugs.com.

By Stephanie Brown HealthDay Reporter

THURSDAY, Feb. 6, 2025 -- The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in patients with advanced Parkinson disease, according to a news release from Supernus Pharmaceuticals.

Onapgo is the first and only wearable subcutaneous apomorphine infusion device that provides continuous treatment during the waking day, offering patients more consistent control of motor fluctuations. The product is expected to be available in the second quarter of 2025. The launch will be supported by a team of experts, including a robust nurse education program.

The efficacy and safety of Onapgo were determined in a phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study involving 107 patients. At 12 weeks from baseline, patients using Onapgo (compared with placebo) experienced a significantly reduced amount of daily OFF time (reduction of 2.6 versus 0.9 hours). This finding was accompanied by a significant increase in daily GOOD ON time (2.8 versus 1.1 hours). Greater improvements in daily OFF and GOOD ON times were seen as early as the first week of treatment and were maintained throughout all measured time points. Commonly reported adverse events (≥10 percent incidence) included infusion-site nodule, nausea, excessive sleepiness, infusion-site skin irritation, headache, and insomnia.

"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."

Approval of Onapgo was granted to Supernus Pharmaceuticals.

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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2025-02-07 06:00

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