FDA Approves First Subcutaneous 24-Hour Continuous Levodopa-Based Infusion for the Treatment of Advanced Parkinson Disease

Vyalev (foscarbidopa and foslevodopa; AbbVie, North Chicago, IL) has been granted Food and Drug Administration (FDA) approval for the treatment of motor fluctuations in adults with advanced Parkinson disease (PD). Vyalev is the first subcutaneous 24-hour continuous infusion of levodopa-based therapy to receive FDA approval for the treatment of motor fluctuations in this population. Treatment with Vyalev is initiated in a health care provider office, and the medication is delivered by a wearable pump for up to 24 hours per day. This method of administration enables patients to manage treatment at home without traveling to receive their infusion.

The FDA approval is based on results of a 12-week, randomized, double-blind, phase 3 clinical trial (NCT04380142) evaluating the safety and efficacy of Vyalev vs oral immediate-release levodopa/carbidopa (LD/CD) in adult participants with advanced PD, as well as results of a separate 52-week, open-label, phase 3 trial (NCT03781167) assessing the long-term safety and efficacy of Vyalev. Individuals treated with Vyalev experienced superior improvement in "on" time without troublesome dyskinesia vs those taking oral immediate-release LD/CD. The most common adverse reactions (ARs) (occurring in ≥10% of patients and more frequently than with oral LD/CD) included infusion site events, hallucinations, and dyskinesia, and all ARs were non-serious and mild to moderate in severity.

"For too long, the Parkinson's community has had limited treatment options for advanced disease. Due to the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required," said Robert A. Hauser, MD, MBA, Professor of Neurology and Director of the Parkinson's and Movement Disorder Center at the University of South Florida. "This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night."