February 2025

NEUROSCIENCES

VYALEV: WHAT TO KNOW ABOUT THE NEW TREATMENT FOR ADVANCED PARKINSON’S DISEASE

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Danny Bega, MD shares key information about VYALEV™, the first and only subcutaneous 24-hour levodopa infusion for patients with advanced Parkinson’s disease (PD).  
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Key Takeaways
  • VYALEV is an FDA-approved continuous infusion treatment for adults with advanced PD.
  • It aims to minimize “off” periods when symptoms return between doses of carbidopa/ levodopa.  
  • It provides a steady delivery of levodopa (in the form of foscarbidopa/foslevodopa) for 24 hours, allowing for more consistent symptom management.
  • It can be particularly beneficial for:
    • Patients who haven’t found smooth or consistent relief with traditional oral medications
    • Patients who require complicated oral medication regimens due to motor fluctuations

How Does VYALEV Work?  
  • VYALEV is a wearable infusion pump that delivers medication 24/7.
  • Benefits:
    • Helps reduce "off” periods caused by fluctuating drug levels
    • Offers more stable symptom control than traditional oral medications
    • Portable design allows for temporary pauses during daily activities like showering
    • Allows for programmable “extra doses” for on-demand needs
    • Route of delivery does not rely on gastrointestinal absorption in the same way that oral medications do
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Key Findings From Clinical Trials
  • Patients experienced an average reduction of 2.75 hours of “off” time daily.
  • A 52-week study showed:
    • An average increase of 3.8 hours of "on" time without dyskinesia
    • A reduction of 3.5 hours in "off" time
    • Ability to continue treatment overnight led to the percentage of patients unable to initiate movement in the morning dropping from 78% to 28%

Potential Side Effects
VYALEV may cause:
  • Drowsiness
  • Hallucinations
  • Compulsive behavior
  • Dyskinesia
  • Infusion site reactions (redness, swelling, pain, itching or infection)

Considerations for Physicians
  • Assess your patient’s ability to use the infusion pump; training is required, and nurse educators are available.
  • Dosing conversion calculators are available on the product website.
  • Patients should keep a backup supply of oral PD medications.
  • Ongoing monitoring of efficacy and side effects, particularly at the infusion site, is essential.
  • Regular/good skin hygiene is critical to safe usage.
 
VYALEV Availability
  • As of December 2024, VYALEV is available to patients with private insurance.
  • Medicare coverage is still pending.
  • The manufacturer plans to offer financial assistance programs and educational resources for eligible patients.
  • More widespread access is expected in the future.
Danny Bega, MD, Associate Professor, Neurology (Movement Disorders) at Northwestern Medicine

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