U.S. approves “milestone” Parkinson’s treatment for 2025 release

Story: 2025 C.E.  |  Last updated: April 29, 2026

People living with Parkinson’s disease in the U.S. will soon have access to a wearable device that delivers continuous symptom relief around the clock — no surgery required. The U.S. Food and Drug Administration has approved Onapgo, a subcutaneous infusion device developed by Supernus Pharmaceuticals, with commercial availability expected by the end of 2025 C.E.

At a glance

• Onapgo approval: The FDA cleared the device for continuous subcutaneous infusion of apomorphine hydrochloride, giving U.S. patients a non-surgical option for managing advanced Parkinson’s symptoms.
• Parkinson’s “off” time: In clinical trials, patients using Onapgo reduced their daily off episodes — periods when levodopa wears off and motor symptoms worsen — by an average of 2.47 hours compared to 0.58 hours for placebo.
• Apomorphine infusion: Unlike oral medications, the device bypasses the gut entirely, delivering the drug directly through the skin and into the bloodstream for more predictable symptom control.

Why “off” time matters so much

For people with Parkinson’s, the standard treatment — levodopa — works well in the early years. But as the disease progresses, its effects become less consistent. Patients cycle between “on” periods, when medication is working and movement feels manageable, and “off” periods, when it isn’t.

Those off episodes can strike at any hour. They bring a return of tremors, stiffness, and the uncontrolled movements known as dyskinesia. Over time, they erode independence and quality of life for the more than 10 million people worldwide — including around one million Americans — living with the condition.

“These on-again, off-again changes are disruptive and can happen at any time,” said Andrea Merriam, CEO of the Parkinson & Movement Disorder Alliance. “Consistent daily control of ‘off’ time is key to improving how patients feel and move.”

What makes Onapgo different

The active ingredient in Onapgo — apomorphine hydrochloride — has been used in Parkinson’s treatment since 2004 C.E., originally approved under the brand name Apokyn as an injection pen used up to five times daily. The new device replaces those repeated injections with a small, lightweight wearable that provides a steady, continuous dose.

The key advantage is how the drug enters the body. Because it goes under the skin rather than through the stomach, it skips the gut entirely. That matters because Parkinson’s disease itself can slow digestion, making oral medications absorb unpredictably.

“With Onapgo, the continuous infusion of apomorphine directly stimulates postsynaptic dopamine receptors with no metabolic conversion needed,” said Dr. Stuart Isaacson, Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton, Florida, who served as a clinical trial investigator. “The subcutaneous delivery bypasses the GI tract and enters the brain, which can allow for more predictable symptom improvement.”

Three decades of European evidence

While the approval is new for the U.S., the underlying therapy has a long track record elsewhere. Continuous subcutaneous apomorphine infusion has been used in Europe for roughly 30 years, helping thousands of patients manage motor fluctuations.

“Today’s approval means patients in the U.S. who are not responding well to their current treatment regimen will now have the option of using a small and lightweight wearable device to deliver a continuous infusion without the need for an invasive surgical procedure,” said Dr. Rajesh Pahwa, professor of Neurology at the University of Kansas School of Medicine and another trial investigator.

That last point is significant. Existing options for continuous drug delivery — including a pump system approved by the FDA for AbbVie late in 2024 C.E. — can require surgical implantation. Onapgo offers a comparable benefit without going under the knife.

What comes next

Supernus Pharmaceuticals spent more than four years securing FDA approval for Onapgo, and the launch will be paired with an education program for healthcare professionals. The goal is to help providers identify which patients are most likely to benefit — particularly those whose levodopa regimen has become less reliable over time.

The trial results were broadly encouraging: the treatment was generally well tolerated, and investigators reported no unexpected safety concerns. That said, six patients did withdraw from the trial due to side effects, a reminder that no treatment works equally well for everyone. Long-term real-world data will be important for understanding how Onapgo performs outside the controlled trial setting.

For now, though, the approval marks a meaningful step. As Kelly Papesh, executive director of the Association of Movement Disorder Advanced Practice Providers, put it: “This therapy has the potential to help us provide more individualized and effective care to those living with Parkinson’s disease.” The Parkinson’s Foundation estimates that diagnosis rates continue to rise globally, making new treatment options like this increasingly urgent.

Read more

For more on this story, see: New Atlas

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