The subcutaneous drug foslevodopa-foscarbidopa (brand name Produodopa) has been launched in the European Union (EU) for the treatment of advanced Parkinson’s disease, its manufacturer AbbVie has announced.
It becomes the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy available in the EU for the treatment severe motor fluctuations and hyperkinesia (excessive movement) or dyskinesia (involuntary movement) in people living with advanced Parkinson’s disease and whose symptoms are inadequately controlled by other therapies.
The continuous delivery of foslevodopa-foscarbidopa provides levodopa 24-hours a day, which AbbVie said may help patients by extending the period when symptoms are well-controlled – often referred to as ‘On’ time.
‘On’ time signifies when symptoms are controlled, whereas ‘Off’ time occurs when symptoms return between medication doses.
Foslevodopa-foscarbidopa gained marketing authorisation through the European Medicine’s Agency’s decentralised procedure in the third quarter of 2022. The Vyafuser pump for the drug’s subcutaneous delivery received Conformité Européenne (CE) Mark in November of 2023.
Angelo Antonini, professor of neurology at the Department of Neuroscience, University of Padua, Italy, said: ‘This approval represents a significant advancement for those with Parkinson’s disease who have historically had limited treatment options for advanced stages.
‘When oral treatment no longer sufficiently helps with improvement in motor fluctuations, patients need alternative options. Produodopa’s around-the-clock infusion allows for continuous delivery of levodopa, the gold standard of treatment.’
Sustained improvements in Parkinson’s symptoms
The launch was supported by three studies, including the Phase 3, 12-month open-label M15-741 study in which the primary endpoint was to evaluate the safety and tolerability of foslevodopa-foscarbidopa.
Secondary endpoints included changes from baseline in normalised ‘Off’ and ‘On’ time, the percentage of patients reporting morning akinesia – defined as ‘Off’ time upon waking – and total scores from quality-of-life surveys.
Eligible patients included adults 30 years or older diagnosed with levodopa-responsive idiopathic Parkinson’s disease experiencing an average of greater than or equal to 2.5 hours of ‘Off’ time per day, as assessed by patient’s Parkinson’s disease diaries.
The results, published in the Journal of Neurology & Therapy, observed a reduction in motor fluctuations as early as Week 1 and persisted through Week 52, and the percentage of patients experiencing morning akinesia dropped from 77.7% at baseline to 27.8% at week 52.
The researchers concluded that there was a favourable benefit/risk profile and sustained improvements in ‘Off’ time and ‘On’ time without dyskinesia, and morning akinesia as measured by the percentage of patients in early morning ‘Off’ time.
The 12-week Phase 3 M15-736 study and a Phase 1 pharmacokinetic comparability study also supported the launch.
The majority of adverse events (AEs) with foslevodopa-foscarbidopa were non-serious and mild or moderate in severity. The most frequent AEs (greater than or equal to 10%) were infusion site events (infusion site erythema, infusion site cellulitis, infusion site nodule, infusion site pain, infusion site oedema, infusion site reaction, and infusion site infection), hallucination, fall, and anxiety.
Foslevodopa-foscarbidopa was recommended by the UK’s National Institute of Health and Care Excellence in autumn 2023 for treating advanced Parkinson’s with motor symptoms and the final technology appraisal guidance was published on 29 November 2023.
