US pharmaceutical company AbbVie (NYSE: ABBV) announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for VYALEV (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease.

The approval was supported by the pivotal Phase 3, 12-week study evaluating the efficacy of continuous subcutaneous infusion of VYALEV in adult patients with advanced Parkinson's disease 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.

Robert A Hauser, MD, MBA, professor of Neurology and director of the Parkinson's and Movement Disorder Center at the University of South Florida, said: "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. This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night."