Advanced Parkinson’s patients can spend hours each day locked in ‘OFF’ states, periods when tremors, rigidity and immobility return as oral medications wear off. The first multi-country real-world data on continuous 24-hour foslevodopa/foscarbidopa infusion shows the approach cut that OFF time by 2.7 hours daily at six months, with improvements across motor symptoms, sleep, pain, and quality of life. But 29% of the 105 patients across eight countries discontinued the study by Month 6, and 8.6% stopped treatment due to adverse events; hallucinations and injection-site infections were each reported in 5.7% of patients.
The ROSSINI late-breaker abstract, presented at the International Congress of Parkinson’s Disease and Movement Disorders Congress 2025, summarizes data from the eponymous three-year, open-label, two-cohort, multi-country study in adults with advanced idiopathic Parkinson’s. The study includes AbbVie employees among the authors and tracked 105 patients across eight countries who were new to the continuous subcutaneous foslevodopa/foscarbidopa infusion. At baseline, these patients averaged 5.2 hours daily in OFF states despite a mean disease duration of 12.1 years.
At six months, OFF time had dropped by 2.7 hours per day. Dyskinesia—involuntary movements that often accompany Parkinson’s treatment—fell by 1.7 hours daily. Motor exam scores, sleep quality, pain, and quality-of-life measures all improved significantly. About 15% used the pump as monotherapy, with most continuing oral medications alongside the infusion.
The safety profile reflected both neuropsychiatric and device-related events. Hallucinations and injection-site infections each affected 5.7% of patients. Serious adverse events occurred in 12.4% of patients, and two deaths were reported (suspected porphyria with aspiration pneumonia; lymphoma with pleural effusion); the abstract does not specify attribution to study treatment. By Month 6, 29% had discontinued the study; 8.6% specifically stopped treatment due to adverse events.
AbbVie does not break out Vyalev/Produodopa (foscarbidopa/foslevodopa) sales. It’s reported inside “Other neuroscience” rather than as its own line item in SEC filings.
Filed Under: Neurological Disease
