AAN 2026: Switch to Vyalev stops troublesome dyskinesia in trial
Uncontrolled movements stopped within months, per data analysis
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- Parkinson's patients on levodopa/carbidopa often experience troublesome dyskinesia.
- Switching to Vyalev significantly reduced or eliminated dyskinesia within months.
- Vyalev also improved motor symptoms, reduced off time, and enhanced quality of life.
People with Parkinson’s disease who switch from other levodopa/carbidopa formulations to Vyalev (foscarbidopa and foslevodopa) usually see uncontrolled movements stop within a few months of making the switch, according to a new analysis of data from two clinical trials.
A team including scientists at AbbVie, the company that sells Vyalev, presented the analysis at this year’s annual meeting of the American Academy of Neurology (AAN), in a poster titled, “Foslevodopa/Foscarbidopa Reduces Troublesome Dyskinesia in People with Advanced Parkinson’s Disease in Two Phase Three Clinical Trials.”
Parkinson’s disease is caused by the death and degeneration of brain cells responsible for making dopamine, a key signaling molecule. Levodopa/carbidopa is a staple Parkinson’s treatment, traditionally given orally, that works by giving the brain more raw material with which to manufacture dopamine.
This type of treatment is often effective for easing Parkinson’s symptoms, but it has some drawbacks. Over the long term, patients on levodopa/carbidopa often start experiencing bouts of so-called off time, when symptoms aren’t adequately controlled between scheduled doses. These therapies also often cause a side effect known as dyskinesia, which is marked by uncontrolled, jerking movements.
Vyalev is a formulation of levodopa/carbidopa administered via a continuous subcutaneous infusion. It is approved in the U.S. and many other countries to help manage motor fluctuations in people with advanced Parkinson’s. These approvals were based mainly on clinical trial data demonstrating that Vyalev could increase on time, in which symptoms are well controlled without problematic dyskinesia.
Analyzing trial data
The researchers aimed to examine how Vyalev affected dyskinesia in clinical trial participants with advanced Parkinson’s. The analysis included data from two Phase 3 studies (NCT04380142 and NCT03781167) in which participants who had been experiencing more than 2.5 hours of daily off time with oral levodopa/carbidopa formulations were switched to Vyalev for at least three months.
Prior to making the switch, a total of 105 patients in both trials experienced at least one hour of problematic dyskinesia each day.
The new analysis showed that, at follow-up about three months after starting Vyalev, 28 of 40 participants (70%) in the group were no longer experiencing any dyskinesia.
The analysis included data on 74 participants who had been experiencing less than one hour of daily dyskinesia before switching to Vyalev. At the 13-week follow-up, all but five (93%) reported no dyskinesia.
“Many participants with [advanced Parkinson’s] no longer had [troublesome dyskinesia] following treatment with [Vyalev], regardless of the duration of their [troublesome dyskinesia] at baseline,” the researchers said.
Regardless of the amount of dyskinesia before Vyalev, patients also tended to report less daily off time, easing of motor symptoms, and improved quality of life after switching to Vyalev, while those treated with oral levodopa/carbidopa showed little change, or worsening of motor symptoms and quality of life, the scientists said.
Alicia Delano
Wondering if this was discussed as option for individuals with PD as alternative to oral Carbidopa/Levodopa prior to developing dyskinesia? Subcutaneous infusion delivery- or is there a significant enough risk of injection site irritation/infection that would make the risk outweigh benefits? Might be cost prohibitive for many as well. Looks like a promising option but clearly lots of questions still. Thanks!
Sharon Skindell
I am waiting for approval from my health insurance to start Vyalev, and my husband and I are praying we will be able to afford this treatment of PD. Having better days and nights with PD is our goal.
Suzanne Lang
Dyskinesia is definitely a problem in patients, such as my husband who has Parkinson’s Disease and often experiences several hours of dyskinesia. He does take AMANTADINE which helps but is not consistent. I am wondering if or when Vyalev will be available in oral delivery form. Thank you.