The U.S. Food and Drug Administration (FDA) has approved Onapgo (apomorphine hydrochloride) injection, the first and only wearable subcutaneous infusion device for people with advanced Parkinson’s disease. This new treatment helps manage motor fluctuations, which are common as the disease progresses.
How Onapgo Works
Onapgo delivers a continuous supply of apomorphine, a medication that helps reduce OFF time—periods when Parkinson’s medication stops working, causing symptoms to return.
Unlike traditional treatment methods, which rely on oral medications, this wearable pump ensures steady medication levels throughout the waking hours. This helps reduce fluctuations and provides more consistent symptom control.
Supernus Pharmaceuticals, the company behind Onapgo, expects the device to be available in the second quarter of 2025. To support patients, the launch will include a team of specialists and a nurse education program to help with training and proper use of the device.
Clinical Trial Results
The FDA’s approval was based on a 12-week phase 3 clinical trial involving 107 patients. The trial followed a double-blind, placebo-controlled design, meaning neither doctors nor patients knew who was receiving the actual treatment. The study compared the effects of Onapgo to a placebo (a treatment with no active medication).
Here’s what the results showed:
- Reduced OFF time: Patients using Onapgo experienced 2.6 fewer hours of OFF time per day, compared to only 0.9 hours in the placebo group.
- Increased GOOD ON time: These patients also gained 2.8 extra hours of GOOD ON time per day, compared to 1.1 hours in the placebo group.
- Fast-acting benefits: Improvements were noticeable as early as the first week of treatment and remained stable throughout the study.
While the benefits were clear, some patients reported side effects, including:
- Infusion-site nodules (small lumps under the skin)
- Nausea
- Excessive sleepiness
- Infusion-site skin irritation
- Headache
- Insomnia
Why This Approval Matters
Parkinson’s disease is a progressive neurological disorder that affects movement. As the disease advances, many patients experience ON-OFF fluctuations, where their medication works well at times (ON) but loses effectiveness at others (OFF). These fluctuations can make daily life unpredictable, as symptoms like tremors, stiffness, and difficulty moving return unexpectedly.
Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance, emphasized the importance of consistent symptom control. “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,” she said.
Onapgo represents a major step forward because it offers a continuous treatment option that helps stabilize these fluctuations, making daily life more manageable for people with Parkinson’s.
Looking Ahead
With its anticipated launch in 2025, Onapgo could transform Parkinson’s treatment by providing a wearable, easy-to-use solution for patients struggling with motor fluctuations. The success of this device will depend on patient acceptance, ease of use, and long-term benefits.
Future studies may also explore how it compares to other Parkinson’s treatments, such as deep brain stimulation or levodopa-carbidopa intestinal gel therapy.
For now, the approval of Onapgo provides new hope for those with advanced Parkinson’s, giving them a more predictable way to manage their symptoms and regain control over their daily lives.
If you care about Parkinson’s disease, please read studies that Vitamin B may slow down cognitive decline, and Mediterranean diet could help lower risk of Parkinson’s.
For more health information, please see recent studies about how wheat gluten might be influencing our brain health, and Olive oil: a daily dose for better brain health.
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