Produodopa (foscarbidopa/foslevodopa) / AbbVie - LARVOL DELTA

Characteristics and Hospitalization Details of Patients with Advanced Parkinson's Disease Receiving Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa: Real-World First-Year Descriptive Study from Japan. (PubMed, Neurol Ther) - "In real-world clinical practice in Japan, patients with LDp/CDp CSCI tend to be younger and have preserved activities of daily living. Our results implied that patients are often managed with multiple concomitant PD medications rather than with L-Dopa dose titration prior to initiation. Further research is warranted to maximize the benefits of LDp/CDp CSCI and assess its real-world impact on pill burden."

Journal • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

Global net revenues from the neuroscience portfolio were $3.228 billion, an increase of 20.3 percent on a reported basis, or 19.8 percent on an operational basis. (PRNewswire) - "Global Ubrelvy net revenues were $392 million, an increase of 16.0 percent on a reported basis, or 15.9 percent on an operational basis; Global Qulipta net revenues were $350 million, an increase of 30.9 percent on a reported basis, or 30.3 percent on an operational basis; Global Vyalev net revenues were $256 million."

Sales • Dystonia • Migraine • Parkinson's Disease

Continuous subcutaneous levodopa and foslevodopa infusion therapy for motor symptoms of Parkinson disease: A systematic review of observational studies. (PubMed, Medicine (Baltimore)) - "Observational evidence supports continuous subcutaneous levodopa infusion therapies as effective options for reducing motor fluctuations in APD, with sustained benefits reported up to 36 months. ISRs remain the principal tolerability concern, but severe discontinuation-related events are uncommon. Further comparative and long-term studies are needed to better define safety, efficacy, and real-world applicability across diverse populations."

Journal • Observational data • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

Change in Functional Impact of Dyskinesias and Motor Fluctuations With Foslevodopa/Foscarbidopa in Parkinson’s Disease (EAN 2026) - P3 | "Functional impairment from dyskinesias and motor fluctuations significantly improved after LDp/CDp treatment in patients with aPD."

CNS Disorders • Movement Disorders • Parkinson's Disease

ROSSINI 12-Month Interim Results: Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease (EAN 2026) - P, P3 | "ROSSINI interim results demonstrate sustained reductions in PD symptoms following 12M of LDp/CDp treatment with an acceptable safety profile."

Clinical • Late-breaking abstract • CNS Disorders • Movement Disorders • Parkinson's Disease

Transition from subcutaneous levodopa/carbidopa (ND0612) to Foslevodopa/Foscarbidopa in advanced Parkinson's disease. (PubMed, Clin Park Relat Disord) - " Conversion from ND0612 to ABBV-951 appears feasible, and safe in advanced PD. These preliminary observations may provide practical insight in the absence of published data addressing this specific therapeutic transition."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Satisfaction after 6 months of Foslevodopa/Foscarbidopa treatment for advanced Parkinson’s disease: Patient-reported outcomes from the real-world ROSSINI observational study (WPC 2026) - P | "Produodopa (foslevodopa/foscarbidopa). People with aPD reported favorable satisfaction with LDp/CDp treatment received in real-world settings. Patient satisfaction can be an important factor in clinical decision-making and adherence to treatment. Vyalev (foscarbidopa/foslevodopa)."

Clinical • Metastases • Observational data • Patient reported outcomes • Real-world • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

Vyalev and me: A single user's early reflections (WPC 2026) - "Vyalev (foslevodopa/foscarbidopa), approved by the US FDA in October 2024, is the first 24 hour continuous subcutaneous levodopa infusion system...Manufacturer instructions recommend alcohol pads, yet infection prevention studies show that 2% chlorhexidine gluconate (CHG) in 70% isopropyl alcohol provides longer antimicrobial protection and lowers catheter related infections by 40–49%...Stable plasma levels and fewer motor fluctuations improve life quality. Future Vyalev iterations integrating CHG based infection control, gentler skin protection, and simplified device design could lower infection (28%) and discontinuation (5%) rates, supporting safer, more autonomous treatment as PD advances."

Addiction (Opioid and Alcohol) • CNS Disorders • Gastrointestinal Disorder • Infectious Disease • Movement Disorders • Parkinson's Disease

Improvement in sleep disturbances is associated with enhanced motor function in advanced Parkinson’s disease with Foslevodopa/Foscarbidopa treatment: post hoc analysis of Foslevodopa/Foscarbidopa phase 3 trials (WPC 2026) - "Participants with PDSS-2 scores ≥18 at baseline, who experienced a reduction to <18 after LDp/CDp treatment, also showed significant improvements in motor symptoms and ADLs. These findings suggest that improvement of sleep disturbances is associated with greater daytime motor benefits, and that restoring better nights may potentially contribute to better days in aPD."

Metastases • P3 data • Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder

Study To Assess Adverse Events and Change in Disease Activity Of 24-hour Continuous Subcutaneous Infusion Of ABBV-951 In Adult Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P3 | N=118 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Adverse events • Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

LS-46 Outpatient initiation of VYALEV therapy (JSNE 2026) - No abstract available

Clinical

Outpatient initiation of VYALEV therapy in the University Hospital (JSNE 2026) - No abstract available

Clinical

Outpatient initiation of VYALEV therapy in clinics (JSNE 2026) - "Sponsored by: AbbVie GK"

Clinical

An Observational Study of Subcutaneous Infusion of ABBV-951 to Assess Change in Disease Activity and Adverse Events In Adult Japanese Participants With Advanced Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=250 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2026 ➔ Jan 2027 | Trial primary completion date: Jul 2026 ➔ Jan 2027

Adverse events • Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease (clinicaltrials.gov) - P3 | N=130 | Completed | Sponsor: AbbVie | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

Real-World Safety and Effectiveness of 24-Hour Foslevodopa/Foscarbidopa in Parkinson's Disease: ROSSINI Study 6-Month Interim Results. (PubMed, Neurol Ther) - P, P3 | "ROSSINI demonstrates reductions in motor fluctuations and nonmotor symptoms, and increased quality of life in patients with aPD after 6 months of LDp/CDp treatment. The safety profile was consistent with clinical trials."

Journal • Real-world evidence • CNS Disorders • Movement Disorders • Pain • Parkinson's Disease • Sleep Disorder

Subcutaneous foslevodopa/foscarbidopa (LDp/CDp) in advanced Parkinson's disease (aPD): societal cost impact analysis for the UK, France, Germany, Spain, and Canada. (PubMed, J Med Econ) - "LDp/CDp has been shown to significantly improve OFF-time burden in patients with aPD, compared with BMT. Once the costs of professional and informal care are taken into account, the additional acquisition costs of LDp/CDp are more than offset, yielding a net societal saving."

HEOR • Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

ROSSINI: Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease (clinicaltrials.gov) - P=N/A | N=427 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • HEOR • Real-world evidence • CNS Disorders • Movement Disorders • Parkinson's Disease

Phase 3 Post Hoc Analysis Shows Foslevodopa/Foscarbidopa Reduces Troublesome Dyskinesia in Advanced Parkinson Disease (NeurologyLive) - "At baseline, more than one-third of participants reported any TSD, including 27 of 74 participants (36.5%) in the RCT and 99 of 244 participants (40.6%) in the OLT. Among those with at least 1 hour of TSD at baseline, 22 of 74 participants (29.7%) in the RCT and 83 of 244 participants (34.0%) in the OLT met this threshold. In this subgroup, 8 of 22 participants (36.4%) in the RCT and 48 of 83 participants (57.8%) in the OLT had no TSD at the final visit...This post hoc analysis, presented at the 2026 American Academy of Neurology (AAN) Annual Meeting...Among participants with more than 1 hour of TSD at baseline, researchers noted that 12 of 74 participants (16.2%) in the RCT and 66 of 244 participants (27.0%) in the OLT were included in this subgroup."

P3 data • Parkinson's Disease

Foslevodopa+foscarbidopa for advanced Parkinson disease. (PubMed, Aust Prescr) - No abstract available

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

In brief: New warnings for carbidopa/levodopa products. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Foslevodopa/Foscarbidopa Improves Pain in People with Advanced Parkinson’s Disease Who Have Uncontrolled Motor Fluctuations: Interim Results From the Real-world ROSSINI Study (AAN 2026) - P | "Conclusions LDp/CDp led to rapid and strong clinically significant improvements in PD-related pain that were sustained through 6 months, with improvements in KPPS total score exceeding the minimal clinically important difference threshold of 3.0 (Taghizadeh 2023). These findings suggest additional benefits of continuous dopaminergic stimulation."

Clinical • Metastases • Real-world • Real-world evidence • CNS Disorders • Dystonia • Movement Disorders • Pain • Parkinson's Disease

Effectiveness of Foslevodopa/Foscarbidopa in Subgroups of Patients Earlier within Advanced Parkinson’s Disease in an Interim Dataset of ROSSINI (AAN 2026) - P | "Conclusions Interim results from small subgroups of patients earlier within aPD suggest that LDp/CDp therapy may yield similar RW improvements in motor complications and quality of life as the overall population. Further research with larger patient numbers is warranted."

Clinical • Metastases • CNS Disorders • Movement Disorders • Parkinson's Disease

Foslevodopa/Foscarbidopa Subcutaneous Infusion Safety and Efficacy in Patients with and Without Prior Deep Brain Stimulation. (PubMed, Adv Ther) - P3 | "While limited by small prior DBS patient numbers, this post hoc study suggests generally similar overall baseline, safety, and efficacy profiles in LDp/CDp-treated prior DBS and no DBS."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

ProParkB: A Study to Assess Change in Disease Symptoms in Adult Participants With Advanced Parkinson Disease Using Subcutaneous Foslevodopa/Foscarbidopa in Belgium (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: AbbVie | Trial completion date: Dec 2027 ➔ Sep 2028 | Trial primary completion date: Dec 2027 ➔ Sep 2028 | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease