At the European Academy of Neurology (EAN) 2026 virtual congress, AbbVie presented new 12-month interim data from the ROSSINI study, supporting the real-world safety and effectiveness of Produodopa in patients with advanced Parkinson’s disease. Sustained improvements were observed across motor fluctuations, non-motor symptoms, and selected quality-of-life outcomes. Positive real-world evidence (RWE) for Produodopa could boost clinician confidence in a crowded levodopa market, says GlobalData, a leading intelligence and productivity platform.

Produodopa is the first-to-market, non-surgical, 24-hour/day continuous subcutaneous infusion therapy for adults with advanced Parkinson’s disease whose motor fluctuations remain inadequately controlled on oral medications. The ROSSINI study is an ongoing, three-year, multi-country, prospective observational study evaluating the long-term safety and effectiveness of Produodopa in routine clinical practice.

Treatment with Produodopa was associated with sustained reductions in motor fluctuations through 12 months. Daily OFF time decreased from 5.2 hours at baseline to 3.0 hours at month 12, while dyskinesia time decreased from 3.5 hours to 1.8 hours. Improvements were observed as early as week 2 and were generally maintained throughout the 12-month interim period.

Benefits were also observed across several nonmotor and disease-specific outcomes. Parkinson’s disease-related sleep disturbance, pain, gastrointestinal dysfunction, and freezing of gait scores all improved over 12 months. The reductions in sleep disturbance and pain exceeded the reported minimal clinically important difference thresholds, highlighting the potential broader clinical value of continuous subcutaneous levodopa delivery beyond motor symptom control.

Graysen Vigneux, Healthcare Analyst at GlobalData, comments: “Advanced Parkinson’s disease management is not only about reducing OFF time. Non-motor symptoms, including sleep disturbance, pain, and gastrointestinal dysfunction, can have a major impact on daily functioning and quality of life. The improvements reported across these measures suggest that Produodopa may address a wider symptom burden in routine practice.”

Quality-of-life findings were more modest in the overall cohort, with the 39-item Parkinson’s Disease Questionnaire summary index decreasing from 35.5 at baseline to 32.6 at month 12. However, a subgroup of younger patients with shorter disease duration experienced a larger reduction, with scores decreasing from 31.3 to 24.0.

Vigneux adds: “Although preliminary and based on a small patient cohort, this finding may suggest that patients earlier in the advanced disease course could derive greater quality-of-life benefit.”

The safety profile remained broadly consistent with previous clinical experience. Any adverse event was reported in 74.1% of patients, serious adverse events in 28.4%, and adverse events leading to withdrawal in 11.4%. The most commonly reported treatment-emergent adverse events were infusion-site infection, infusion-site reaction, and hallucination. Six deaths were reported, all of which were considered unrelated to the study treatment.

Vigneux concludes: “These data strengthen the case for Produodopa as a real-world, nonsurgical, device-aided treatment option for advanced Parkinson’s disease. However, continued follow-up will be important to confirm the durability of benefit, better characterize long-term safety, and determine which patient subgroups are most likely to achieve meaningful quality-of-life improvements.”