Real-World Data Show Improvements in Parkinson Disease Outcomes After 6-Months of Foslevodopa/Foscarbidopa Treatment

Early real-world data from the ROSSINI clinical trial (NCT06107426) demonstrated improvements in both motor and non-motor symptoms, including quality of life (QoL) outcomes, as well as a consistent safety profile for treatment-naïve individuals with Parkinson disease (PD) receiving 6 months of Vyalev (foscarbidopa and foslevodopa; AbbVie, North Chicago, IL) treatment. These results were presented at the 2025 International Congress of Parkinson’s Disease and Movement Disorders.

ROSSINI is a 3-year, international observational study designed to assess the real-world safety and efficacy of Vyalev in 2 cohorts of people with advanced idiopathic PD. Six-month interim data from 105 participants in cohort A—a group of treatment-naïve individuals who initiated continuous subcutaneous infusions of Vyalev—were evaluated for changes in “Off” time as a primary end point (modified Movement Disorder Society–Unified Parkinson’s Disease Rating Scale [MDS-UPDRS] item 4.3).

Individuals in cohort A showed statistically significant, clinically meaningful, sustained improvements from baseline to 6 months in:

• “Off” time (-2.7 hours; P<.001)
• Dyskinesia time (-1.7 hours; P<.001)
• MDS-UPDRS III scores (-5.3; P<.001)
• Parkinson’s Disease Sleep Scale-2 (PDSS-2) scores (-6.0; P<.001)
• King’s Parkinson’s Disease Pain Scale (KPPS) scores (-8.5; P<.001)
• 39-item Parkinson’s Disease Questionnaire (PDQ-39) scores (-5.3; P<.001) from baseline to 6 months.

An acceptable safety profile was confirmed in routine clinical practice. Over half of participants reported ≥1 adverse event, with hallucination and injection site reactions being the most common. While most were mild or moderate, 8.6% discontinued treatment due to AEs.

Source: Jost W, Bergquist F, Evans A, et al. Real-world safety and effectiveness of foslevodopa/foscarbidopa in Parkinson’s disease: ROSSINI study 6-month interim results. Presented at: International Congress of Parkinson’s Disease and Movement Disorders; October 5–9, 2025; Honolulu, HI.