FDA Approves Supernus' ONAPGO for Motor Fluctuations in Advanced Parkinson's Disease
核心洞察
The FDA has approved ONAPGO (搜索) (apomorphine hydrochloride) as the first subcutaneous apomorphine infusion device for treating motor fluctuations in advanced Parkinson's disease (搜索).
ONAPGO (搜索), a wearable device, provides continuous subcutaneous apomorphine infusion, offering more consistent control of OFF time for Parkinson's patients.
Clinical trials demonstrated that ONAPGO (搜索) significantly reduced daily OFF time by 2.6 hours compared to placebo, with improvements seen as early as week 1.
The FDA has approved Supernus Pharmaceuticals' ONAPGO (搜索) (apomorphine hydrochloride) injection, marking it as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson's disease (搜索) (PD). This approval offers a new option for patients experiencing 'OFF' episodes, where symptoms return between medication doses, and is based on data demonstrating significant reductions in daily 'OFF' time and improvements in 'ON' time. Supernus plans to launch ONAPGO in the U.S. in the second quarter of 2025, with a support team of experts and a nurse education program.
Clinical Trial Data
The FDA's decision was supported by data from a Phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study involving 107 patients. The study evaluated the efficacy and safety of ONAPGO (搜索), with the primary endpoint being the mean change in total daily OFF time from baseline to the end of the treatment period, assessed via patient diaries. Key secondary endpoints included the mean change in daily 'GOOD ON' time (ON time without troublesome dyskinesia (搜索)) and the Patient Global Impression of Change (PGIC).
Results from the Phase 3 study showed that ONAPGO (搜索) significantly reduced daily OFF time by 2.6 hours compared to a 0.9-hour reduction with placebo (p=0.0114). Additionally, ONAPGO-treated patients experienced a 2.8-hour increase in daily 'GOOD ON' time, compared to a 1.1-hour increase in the placebo group (p=0.0188). Improvements in both OFF time and GOOD ON time were observed as early as week 1 and sustained throughout the study. A significantly greater proportion of ONAPGO-treated patients reported improvements in their overall health compared to those receiving placebo (79% vs. 24%; p<0.0001).
Expert Commentary
Rajesh Pahwa, M.D., Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, noted the established history of continuous subcutaneous apomorphine infusion in Europe and emphasized the significance of ONAPGO (搜索)'s approval for U.S. patients who are not responding well to current treatments like levodopa. Stuart Isaacson, M.D., Director of Parkinson's Disease (搜索) and Movement Disorders Center of Boca Raton, Florida, highlighted that ONAPGO bypasses the GI tract, allowing for more predictable symptom improvement by directly stimulating postsynaptic dopamine receptors.
Device Details and Availability
ONAPGO (搜索) is a wearable subcutaneous infusion device designed to provide continuous treatment during waking hours, aiming for more consistent control of OFF time. It delivers apomorphine directly into the brain, bypassing the gastrointestinal tract, which can improve symptom management. Supernus plans to launch ONAPGO in the U.S. in the second quarter of 2025, supported by a dedicated support program, including nurse education and access assistance.
Parkinson's Disease Context
Parkinson's disease (搜索) affects nearly one million people in the U.S. and over 10 million worldwide. It is a progressive neurodegenerative disorder characterized by tremors, muscle rigidity, and difficulties with movement and balance. As the disease progresses, patients often experience fluctuations between 'ON' periods, when medication is effective, and 'OFF' periods, when symptoms return. ONAPGO (搜索) offers a treatment option to reduce these fluctuations and improve the predictability of symptom control.
Safety and Adverse Events
The most common adverse events reported with ONAPGO (搜索) in clinical trials (incidence of 10% or more) included infusion-site nodules, nausea, somnolence, infusion-site erythema, dyskinesia (搜索), headache, and insomnia. Patients are advised to report any negative side effects to the FDA.