Feb. 6. 2025 – The FDA has approved a new wearable device for adults with advanced Parkinson’s disease.
Sold as Onapgo, this device gives a steady dose of apomorphine – a medicine that helps people with Parkinson’s disease move more easily – under the skin to help manage movement issues and daily symptom changes.
Parkinson’s disease is a progressive condition affecting about 1 million people in the United States and over 10 million globally. It happens when the brain doesn’t produce enough dopamine, causing symptoms like tremors, muscle stiffness, balance issues, and slow movements. These symptoms can vary throughout the day, with periods of better control ("on" times) and worsening symptoms ("off" times).
People with advanced Parkinson’s disease have uncontrollable movements (dyskinesia), making daily tasks difficult. While there’s no cure, current treatments help with symptoms, but people who have Parkinson's often face fluctuating "on" and "off" times, highlighting the need for continuous relief.
Onapgo is a small lightweight device that delivers apomorphine directly into the bloodstream, bypassing the digestive system. It mimics dopamine to help manage Parkinson’s symptoms, providing a steady, continuous dose under the skin. This noninvasive device helps reduce movement problems during "off" periods, offering more predictable symptom relief.
The FDA approval was based on a clinical trial involving 107 people. After 12 weeks, Onapgo reduced daily "off" time by 2.6 hours and increased "on" time by 2.8 hours, compared to 0.9 hours and 1.1 hours with the placebo. These improvements were seen as early as the first week and continued throughout the study. People using Onapgo also reported better overall well-being.
The most common side effects included bumps and redness at the infusion site, nausea, sleepiness, dizziness, headaches, anemia, and trouble falling asleep or staying asleep (insomnia).
Supernus Pharmaceuticals, Onapgo’s maker, announced in a news release that the device will be available in the second quarter of 2025. Before starting treatment, patients should discuss their medical history with their doctors, especially if they have daytime sleepiness, dizziness, heart problems, high or low blood pressure, a history of stroke, breathing issues, kidney or liver problems, a mental health condition, or if they are pregnant, planning to get pregnant, or breastfeeding. They should also tell their health care providers about all the prescription medications, over-the-counter drugs (for nausea, vomiting, cold, or fever), vitamins, or supplements they take to avoid possible reactions. The company has warned against injecting Onapgo into a vein (intravenously), as it can cause blood clots and other serious complications.
