Continuous Infusion Treatment for Parkinson’s Approved by FDA

AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has approved VYALEV™ (foscarbidopa and foslevodopa), marking the first subcutaneous 24-hour infusion therapy based on levodopa for treating motor fluctuations in adults with advanced Parkinson's disease (PD).

Robert A. Hauser, M.D., MBA, a professor of neurology and director of the Parkinson's and Movement Disorder Center at the University of South Florida, highlighted that this new non-surgical treatment offers continuous levodopa delivery throughout the day, providing a crucial option for patients whose oral medications have become less effective as their disease progresses.

The FDA's approval was based on a pivotal Phase 3, 12-week study comparing VYALEV's continuous infusion with oral immediate-release carbidopa/levodopa (CD/LD IR) in advanced PD patients, along with a 52-week open-label study on its long-term safety and efficacy. Results showed that VYALEV significantly improved motor fluctuations, increasing "on" time (periods of optimal symptom control) and reducing "off" time (when symptoms return) compared to oral CD/LD IR.

Most adverse reactions (ARs) were mild or moderate, with common side effects including infusion site reactions, hallucinations, and dyskinesia.

Roopal Thakkar, M.D., executive vice president of research and development and chief scientific officer at AbbVie, emphasized the importance of this treatment in helping advanced PD patients manage motor fluctuations through continuous 24-hour levodopa delivery.

Parkinson’s disease is a chronic and progressive movement disorder characterized by symptoms like tremors, muscle rigidity, and balance issues due to the loss of dopamine-producing cells in the brain.

VYALEV availability will depend on individual insurance plans, with Medicare coverage expected in the latter half of 2025. Patients are advised to consult their healthcare provider for more information about this treatment.