FDA approves Vyalev (foscarbidopa + foslevodopa) subcutaneous 24-hour infusion of levodopa-based therapy for advanced Parkinson's disease

"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, M.D., 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." 

The approval was supported by the pivotal Phase III, 12-week study evaluating the efficacy of continuous subcutaneous infusion of Vyalev in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR), along with a 52-week, open-label study which evaluated the long-term safety and efficacy of Vyalev. Findings from the pivotal study showed patients receiving Vyalev  demonstrated superior improvement in motor fluctuations, with increased "on" time without troublesome dyskinesia and decreased "off" time, compared with oral CD/LD IR. "On" time refers to the periods of time when patients are experiencing optimal motor symptom control while "off" time is when symptoms return.

The majority of adverse reactions (ARs) with Vyalev were non-serious and mild or moderate in severity. The most frequent ARs (greater than or equal to 10 percent and greater than CD/LD IR incidence) were infusion site events, hallucinations, and dyskinesia.