News|Articles|October 15, 2025

Interim ROSSINI Data Highlight Foslevodopa/Foscarbidopa’s Impact in Advanced Parkinson Disease

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Key Takeaways

  • Foslevodopa/foscarbidopa (LDp/CDp) significantly reduces OFF time, dyskinesia, and other symptoms in advanced Parkinson's disease over six months.
  • The ROSSINI study employs mixed-effects models to assess LDp/CDp's efficacy and safety, confirming its acceptable safety profile in clinical practice.
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New real-world data presented at MDS 2025 demonstrated that foslevodopa/foscarbidopa reduced motor fluctuations and improved quality of life in patients with advanced Parkinson disease over 6 months.

Late-breaking data from cohort A of the ongoing observational ROSSINI study (NCT06107426), presented at the 2025 International Congress of Parkinson’s Disease and Movement Disorders (MDS), held October 5-9, in Honolulu, Hawaii, indicated that use of foslevodopa/foscarbidopa (LDp/CDp; Vyalev; AbbVie) led to sustained improvements in motor and nonmotor symptoms among patients with advanced Parkinson disease (PD) after 6 months of treatment.1

In cohort A (n = 105), using a data cut-off of April 24, 2025, patients treated with LDp/CDp experienced statistically significant 6-month reductions in OFF time (-2.7 hours), dyskinesia time (-1.7 hours), Movement Disorders Society Unified PD Rating Scale part III (-5.3), PD Sleep Scale (-6.0), King's PD Pain Scale (-8.5), and 39-item PD Questionnaire (-5.3) from baseline to 6 months. Notably, measures of freezing of gait and gastrointestinal dysfunction also showed significant improvement over the 6-month period.

ROSSINI is an ongoing 3-year multicountry, prospective, observational, 2-cohort, open-label study assessing the efficacy and safety of LDp/CDp among adults with advanced idiopathic PD in routine clinical practice. In the study, participants naive to LDp/CDp (cohort A) or transitioning from open-label extension studies of LDp/CDp (NCT04379050/NCT04750226; cohort B) received LDp/CDp in routine clinical practice based on the locally approved label.

The primary end point of ROSSINI was the change from baseline to 36 months in OFF time, a typical standard outcome for PD trials. Mixed-effects models for repeated measurements were utilized for continuous outcomes, and generalized linear mixed-effects models were used for categorical outcomes, both adjusted for country.

READ MORE: Phase 2 Controlled Trial Tests Potential of Probiotics in Parkinson-Related Depression, Mood Disorders

Presented by lead author Wolfgang H. Jost, MD, professor of neurology, and chief neurologist at the Parkinson- Klinik Ortenau, in Wolfach, Germany, cohort A participants had a mean age of 68.5 years (SD, 9.5), a mean PD duration of 12.1 years (SD, 5.3), and an average OFF time of 5.2 hours (SE, 0.5) at baseline. Authors noted that the mean daily levodopa-equivalent dose remained stable from baseline to 6 months (1450 mg to 1511 mg). The LDp/CDp base infusion rate increased from 56.1 mg/h at baseline to 66.1 mg/h at 1 month but remained largely stable thereafter (6 months, 67.9 mg/h). Over the 6-month period, 15.2% of patients received LDp/CDp as monotherapy.

Findings from the analysis revealed that the therapy demonstrated an acceptable safety profile in routine clinical practice, with the majority of adverse events (AEs) being nonserious, mild to moderate, and manageable. Overall, 58 patients (55.2%) reported at least 1 AE (55.2%), with hallucinations and injection-site infections each occurring in 6% of patients. Most AEs were mild or moderate, 18 were severe, and 13 were classified as serious. At 6 months, 30 patients discontinued the study (29%), including 9 patients because of AEs (8.6%); hallucination was the only AE reported more than once (n = 2) as the reason for discontinuation.

LDp/CDp became the first and only subcutaneous 24-hour infusion of levodopa-based therapy approved by the FDA for the treatment of motor fluctuations in patients with PD in October 2024. Findings from the phase 3 M15-736 study (NCT04380142), along with a 52-week open-label M15-741 study (NCT03781167) supported the agnecy’s decision to approve the therapy. In the original phase 3 trial, patients treated with LDp/CDp gained an increase of 2.72 hours in good ON time without troublesome dyskinesia compared with 0.97 hours for those on oral CD/LD-IR (P = .0083).2

In a recent NeurologyLive® Peer Exchange episode, a panel of movement disorder experts discussed how health care providers have incorporated continuous subcutaneous infusion systems, such as LDp/CDp, into their clinical practice. The experts featured in the panel included Fernando Pagan, MD; Jason Aldred, MD, FAAN; Maria Cristina Ospina, MD; and Rajeev Kumar, MD. In this video series, the panel discussed how to navigate the complexities of choosing the most effective pharmacological and nonpharmacological treatment regimens for patients with advanced PD.

Click here for more coverage of MDS 2025.

REFERENCES
1. 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: 2025 MDS Congress; October 5-9; Honolulu, Hawaii. LBA-15.
2. U.S. FDA Approves VYALEV™ (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease. News release. AbbVie. October 17, 2024. Accessed October 14, 2025. https://news.abbvie.com/2024-10-17-U-S-FDA-Approves-VYALEV-TM-foscarbidopa-and-foslevodopa-for-Adults-Living-with-Advanced-Parkinsons-Disease

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