Thursday, June 12, 2025
VYALEV - a continuous levodopa-based therapy
Support Group Meeting - 7:00 - 8:30 p.m.
PRESENTER: Scott Parmelee, MS, MBA
AbbVie Neuroscience: Parkinson’s
Account Executive
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VYALEV™ (foslevodopa/foscarbidopa solution) is a recently FDA-approved continuous 24-hour subcutaneous infusion therapy for advanced Parkinson’s disease. It provides stable levodopa delivery to reduce motor fluctuations including "off" time and dyskinesia, improving "on" time without troublesome dyskinesia. VYALEV represents a non-surgical alternative to device-aided therapies, with evidence from pivotal Phase 3 trials supporting its efficacy and safety in patients inadequately controlled by oral levodopa.
What is VYALEV?
VYALEV (foslevodopa/foscarbidopa) is a formulation of levodopa and carbidopa prodrugs given via continuous subcutaneous infusion for advanced Parkinson's disease patients experiencing motor fluctuations not managed well by oral medications. It delivers levodopa steadily throughout 24 hours, bypassing the digestive system, which can be unreliable in absorption for PD patients, ensuring more consistent symptom control.
Clinical Benefits
The FDA approved VYALEV based on a Phase 3 clinical trial comparing it to oral immediate-release carbidopa/levodopa (CD/LD IR). Key findings include:
A 2.72-hour increase in “on” time without troublesome dyskinesia compared to 0.97 hours for oral therapy over 12 weeks.
Significant reduction in “off” time when symptoms recur due to medication wearing off.
Improvements noted as early as one week and maintained throughout the study duration.
Additional benefits reported in open-label extension studies include reduced morning akinesia, better sleep quality, and improved daily living motor experiences.
How VYALEV Works
VYALEV’s foslevodopa and foscarbidopa are prodrugs that convert enzymatically into levodopa and carbidopa in the body. Carbidopa inhibits peripheral conversion of levodopa to dopamine outside the brain, enhancing levodopa’s availability to the central nervous system where it is converted to dopamine to alleviate PD motor symptoms.
Continuous subcutaneous infusion allows steady plasma levodopa levels, reducing fluctuations seen with oral forms and associated motor complications like dyskinesia and "off" periods.
Administration and Practical Considerations
VYALEV is administered using a wearable pump (Vyafuser) that delivers medication continuously under the skin at adjustable doses to fit individual needs, 24 hours a day.
This method bypasses issues of gastrointestinal absorption variability and food interactions common with oral levodopa.
Patients must have a backup oral levodopa supply in case of pump interruption to avoid withdrawal.
Safety and Side Effects
Infusion site reactions and infections are common; around 28% of patients experienced infections at the infusion site in trials, though most were mild to moderate. About 5% discontinued due to site infections.
Other side effects include hallucinations, dyskinesia, sleepiness or sudden sleep episodes, and possible cardiovascular effects.
Patients must be monitored for hallucinations and sleepiness because continuous dopaminergic stimulation can increase these risks.
Concomitant medications like MAO inhibitors are contraindicated due to hypertensive risk.
Dose adjustments may be necessary based on side effect profiles[1], [3].
Place in Parkinson’s Management
VYALEV is intended for advanced PD patients whose motor symptoms—including fluctuations and dyskinesia—are not adequately controlled with oral medications.
It is a non-surgical alternative to device-assisted therapies like deep brain stimulation, beneficial for those unable or unwilling to undergo surgery.
It may be part of a personalized treatment plan, sometimes used alongside other advanced therapies[4].
Health Disclaimer
This information is not a substitute for professional medical advice. People with Parkinson’s considering VYALEV should discuss with their neurologist or movement disorder specialist whether this treatment is appropriate, considering individual symptom profile and overall health.
Sources
First Continuous Infusion Levodopa System Approved in the United States: What You
Need to Know About VYALEV - Davis Phinney Foundation
https://davisphinneyfoundation.org/continuous-infusion-levodopa-approved-usa/
VYALEV (foscarbidopa/foslevodopa) prescribing information
https://www.rxabbvie.com/pdf/vyalev_pi.pdf
New Continuous Pump Medication for Parkinson’s Completes Trials in Europe | Parkinson's Foundation