New 24-Hour Parkinson’s Treatment Approved by FDA: What You Need to Know About VYALEV

The FDA has approved VYALEV™, a new 24-hour treatment for adults living with advanced Parkinson's disease. This marks a significant step forward, offering continuous motor symptom relief through an innovative, under-the-skin infusion. Here's what that means for patients and caregivers. What Is VYALEV™? VYALEV™ is the first and only subcutaneous (under the skin) 24-hour continuous infusion treatment for Parkinson’s disease. It uses a combination of levodopa and carbidopa, two key ingredients commonly used to manage the motor symptoms of Parkinson’s, like tremors and stiffness. Unlike traditional oral medication that wears off, VYALEV™ provides steady relief throughout the day and night. Who Can Benefit? VYALEV™ is designed for adults with advanced Parkinson’s who experience motor fluctuations. These fluctuations include periods when the usual medication isn’t working well, causing movement problems ("off" time) or when uncontrolled movements occur ("on" time with dyskinesia). In clinical trials, patients using VYALEV™ reported increased "on" time without troublesome dyskinesia, meaning they experienced better motor control for longer periods. How Does It Work? VYALEV™ is delivered through a small pump that infuses the medication under the skin continuously, offering personalized dosing for morning, day, and night. This ensures a stable level of medication in the body, helping to reduce the rollercoaster of symptoms that many Parkinson’s patients face with oral medication. Key Benefits from Clinical Trials In a pivotal 12-week study, patients using VYALEV™ experienced an average of 2.72 more hours of "on" time without troublesome dyskinesia compared to just 0.97 hours for those on traditional oral medications. These improvements started within the first week and lasted throughout the study. Are There Side Effects? The most common side effects reported were infusion site reactions, hallucinations, and dyskinesia. These were generally mild to moderate. Availability and Next Steps While the FDA has approved VYALEV™, availability will depend on individual insurance plans. Medicare coverage is expected by mid-2025. Patients interested in this treatment should speak with their healthcare providers for more information. VYALEV™ offers a new option for people with advanced Parkinson’s disease, providing continuous symptom relief and improving daily quality of life.