FDA Approves Apomorphine Drug-Device for Movement Symptoms in Parkinson Disease
The US Food and Drug Administration (FDA) approved a drug-device combination to treat movement-related symptoms in advanced Parkinson disease. The treatment modality continuously delivers apomorphine under the skin, providing relief for symptoms like tremors and difficulty walking without having to intravenously administer the drug as often as every 2 hours.
“Continuous subcutaneous apomorphine infusion already has a proven and established 30-year history in Europe, where it has helped deliver more consistent control of motor fluctuations for thousands of patients,” said Rajesh Pahwa, MD, Laverne and Joyce Rider Professor of Neurology at the University of Kansas School of Medicine, Director of the Movement Disorder Program at The University of Kansas Health System, and a clinical trial investigator for the infusion therapy.
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The approval of the apomorphine drug-device combination (marketed as Onapgo by manufacturer Supernus Pharmaceuticals) is based on findings from a phase 3, 12-week, multicenter, parallel-group, double-blind, randomized, placebo-controlled study that assessed efficacy and safety in a group of 107 patients with Parkinson disease. Overall, the apomorphine drug-device combination reduced daily periods of “off episodes” by more than 2 hours, compared to less than an hour with placebo.
The most common adverse effects were infusion-site nodule, nausea, somnolence, infusion-site erythema, dyskinesia, headache, and insomnia.
“As the motor symptoms of Parkinson disease worsen over time, patients report alternating states between ON when their medication is working, and OFF when it’s not working optimally,” said
Onapgo is expected to be available in the United States during the second quarter of 2025.
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