The FDA has approved a new wearable device, Onapgo, designed for adults with advanced Parkinson’s disease. This approval marks a significant advancement in the treatment options available for people with this progressive neurological condition, which affects millions worldwide. Onapgo aims to help manage the symptoms of Parkinson’s by providing continuous, steady doses of apomorphine, a medication that mimics dopamine in the brain, thus improving motor function and reducing the debilitating effects of Parkinson’s disease.
Parkinson’s disease occurs when the brain fails to produce enough dopamine, a neurotransmitter crucial for controlling movement. This deficiency leads to the characteristic symptoms of Parkinson’s, including tremors, muscle stiffness, balance issues, and slowed movements. These symptoms fluctuate throughout the day, with patients experiencing periods of better control (“on” times) and more severe symptoms (“off” times). Individuals with advanced Parkinson’s often struggle with uncontrollable movements, known as dyskinesia, which further complicates daily activities.
For many people with Parkinson’s disease, the current treatments provide intermittent relief, but they are not always effective at addressing the fluctuations in symptoms. This is particularly challenging for those who experience long “off” periods, where they face a significant decline in mobility and overall quality of life. Until now, the lack of continuous relief has been a persistent issue, which Onapgo aims to address.
Onapgo is a small, lightweight device that delivers a consistent dose of apomorphine directly under the skin. This subcutaneous infusion allows the medication to bypass the digestive system, ensuring more effective absorption into the bloodstream. By mimicking dopamine, Onapgo helps stabilize motor function during “off” periods, reducing movement problems and providing more predictable symptom relief. The device offers a noninvasive and user-friendly alternative to oral medications and other treatments that may require more frequent adjustments.
The approval of Onapgo was based on the results of a clinical trial involving 107 participants with advanced Parkinson’s disease. Over the course of 12 weeks, those using Onapgo saw significant improvements in their condition. Daily “off” time was reduced by 2.6 hours, while “on” time increased by 2.8 hours compared to the placebo group, which only experienced a 0.9-hour reduction in “off” time and a 1.1-hour increase in “on” time. These improvements were noticed as early as the first week of treatment and continued throughout the study period, with patients reporting enhanced overall well-being.
Despite its promising results, Onapgo is not without potential side effects. The most common side effects reported in the clinical trial included irritation at the infusion site, such as bumps and redness, as well as nausea, dizziness, sleepiness, headaches, anemia, and insomnia. While these side effects were generally mild to moderate, patients are advised to consult with their healthcare providers before starting treatment to ensure it is appropriate for their individual medical conditions.
It is particularly important for patients to discuss their medical history with their doctors before beginning treatment with Onapgo, especially if they have a history of cardiovascular issues, breathing problems, mental health conditions, or kidney and liver concerns. Additionally, patients should inform their healthcare providers of any other medications, including over-the-counter drugs, vitamins, or supplements they are currently taking. It is also essential to avoid injecting Onapgo intravenously, as doing so can lead to severe complications like blood clots.
Onapgo is expected to be available for use in the second quarter of 2025. This new wearable infusion device provides a promising solution for those living with advanced Parkinson’s disease, offering more consistent and predictable symptom management that could greatly improve their quality of life.
