Produodopa (foscarbidopa/foslevodopa) / AbbVie - LARVOL DELTA

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 | Not yet recruiting | Sponsor: AbbVie

New trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Considerations for Initiation and Maintenance of Foslevodopa/Foscarbidopa for Advanced Parkinson's Disease. (PubMed, Mov Disord Clin Pract) - "LDp/CDp is a new treatment option for advanced PD (aPD). Treatment success depends on education, selecting appropriate patients, setting patient expectations, implementing individualized dosing strategies, and managing adverse effects."

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

ONIROS: A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa (clinicaltrials.gov) - P=N/A | N=103 | Recruiting | Sponsor: AbbVie | Trial completion date: Mar 2026 ➔ Jan 2027 | Trial primary completion date: Mar 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder

Bioequivalence of Foslevodopa/Foscarbidopa continuous subcutaneous infusion to arm, thigh, or flank versus abdomen in healthy and advanced Parkinson's disease individuals. (PubMed, Clin Park Relat Disord) - P1 | "The pharmacokinetics of levodopa and carbidopa demonstrated that the abdomen, arm, thigh, and flank are interchangeable sites for CSCI of LDp/CDp. There were no concerning patterns of adverse events."

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

A White Dome at the Infusion Site: Cutaneous Bulging With LDp/CDp Therapy. (PubMed, Mov Disord Clin Pract) - No abstract available

Journal • CNS Disorders • Movement Disorders

ONIROS: A Study to Assess Change in Sleep Disturbances of Adult Participants With Advanced Parkinson's Disease Receiving Subcutaneous Foslevodopa/Foscarbidopa (clinicaltrials.gov) - P=N/A | N=103 | Recruiting | Sponsor: AbbVie

New trial • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder

Foslevodopa/Foscarbidopa in Younger Patients Earlier Within Advanced Parkinson's Disease: Post Hoc Analysis of a Randomized Trial. (PubMed, Neurol Ther) - P3 | "LDp/CDp was associated with significantly greater improvements in motor function and sleep vs orally administered levodopa/carbidopa in younger patients earlier within aPD whose symptoms were inadequately controlled by oral/transdermal therapies. Larger real-world studies are needed to confirm findings."

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

Interim ROSSINI Data Highlight Foslevodopa/Foscarbidopa’s Impact in Advanced Parkinson Disease (NeurologyLive) - "In cohort A (n = 105), using a data cutoff 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....The primary end point of ROSSINI was the change from baseline to 36 months in OFF time, a typical standard outcome for PD trials."

Observational data • Parkinson's Disease

Real-life experience with continuous subcutaneous foslevodopa/foscarbidopa infusion in advanced stage of Parkinson's disease at Villa Margherita (MDS Congress 2025) - "Objective: We present the results of our case series with continuous subcutaneous infusion (CSCI) produodopa in 2024, focusing on tolerability and efficacy, in line with clinical trial findings. We confirm that in a real-life setting CSCI is a safe and efficacious treatment for patients with advanced PD."

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

Improvement in Motor Consistency and Stability with Foslevodopa/Foscarbidopa in Advanced Parkinson's Disease: Post Hoc Analysis of Two Phase 3 Clinical Trials. (PubMed, Neurol Ther) - P3 | "LDp/CDp provided consistent motor symptom control throughout the day, enhanced motor state stability, and reduced motor fluctuation, highlighting LDp/CDp's potential to significantly improve the management of unpredictable motor states and overall quality of life for people with aPD."

Journal • P3 data • Retrospective data • CNS Disorders • Movement Disorders • Parkinson's Disease

Post Hoc analysis: Impact of prior catecholo-methyltransferase Inhibitor use on foslevodopa/ foscarbidopa optimization (EAN 2025) - P3 | " Patients from a 52-week open-label study of LDp/ CDp (NCT03781167) were grouped by prior COMTi (opicapone or entacapone) or no prior(non-COMTi) use. Prior COMTi use does not impact overall efficacy and safety of LDp/CDp. During initial days after conversion, closer monitoring for dosing-related effects like dyskinesias may be advised."

Retrospective data • Movement Disorders • COMT

Analysis of single PDQ-39 items comprising the PDQ-8 shows foslevodopa/foscarbidopa therapy improved PDQ-8 summary index (EAN 2025) - P3 | "Both trial's calculated PDQ-8-SI showed simi - lar nominally significant improvements vs baseline near/over MCID in LDp/CDp-treated patients, as previously reported for PDQ-39-SI. These results suggest evaluating QoL in PD patients using PDQ-8 could obtain results similar to PDQ-39 with re - duced patient/caregiver assessment time burden."

CNS Disorders • Movement Disorders • Parkinson's Disease

ROSSINI: Study in progress assessing longterm foslevodopa/foscarbidopa effectiveness and safety in Parkinson's disease (EAN 2025) - P, P3 | "Final ROSSINI study results will extend findings from previous studies by providing up to 3 years of data on the real-world effectiveness and safety/tolerability of LDp/CDp in advanced PD."

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

Efficacy and Safety of Foslevodopa/Foscarbidopa Monotherapy in Patients with Parkinson's Disease. (PubMed, Mov Disord Clin Pract) - P3 | "LDp/CDp monotherapy treatment may be suitable for up to 96 weeks."

Journal • Monotherapy • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder

New Parkinson’s treatment now available on PBS (Australian Rural & Regional News) - "Australians living with Parkinson’s disease are celebrating after the Federal Government listed a breakthrough treatment on the Pharmaceutical Benefits Scheme (PBS), making it affordable for thousands of patients...VYALEV (foslevodopa with foscarbidopa) is administered through a 24-hour infusion under the skin and helps restore dopamine levels in the brain....The PBS listing ensures this advanced treatment option is now accessible to eligible patients across Australia."

Reimbursement • Parkinson's Disease

AbbVie Beats on Q2 Earnings & Sales, Stock Up on Raised '25 EPS View (Yahoo Finance) - "Sales from the neuroscience portfolio increased 24% to $2.68 billion, driven by higher sales of Botox Therapeutic, depression drug Vraylar and migraine drugs Ubrelvy and Qulipta. Neuroscience sales beat the Zacks Consensus Estimate and our model estimate of $2.47 billion and $2.48 billion, respectively. While Botox Therapeutic sales rose 14.2% to $928 million, sales of Vraylar increased 16.3% to $900 million. Sales of Ubrelvy totaled $338 million, up 47.2%. Qulipta sales increased 76.9% to $267 million. Sales of Vyalev, the recently approved transformative therapy for advanced Parkinson’s disease, totaled $98 million, compared with $63 million in the first quarter."

Sales • Depression • Migraine • Pain • Parkinson's Disease

Onapgo - an apomorphine subcutaneous infusion for Parkinson's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Post hoc exploratory analysis of the effect of foslevodopa/foscarbidopa continuous subcutaneous infusion on nocturia in patients with Parkinson's disease. (PubMed, Clin Park Relat Disord) - P3 | "A significant positive correlation between nocturia and QoL was shown at BL and between Δ BL-wk 12 in the randomized trial (nominal p ≤ 0.05 for both), while open-label results showed no significant correlations. LDp/CDp-treated patients with PD demonstrated significantly improved nocturia with 24-hour therapy, 12-week nocturia improvements were significantly greater than oral therapy, and patient-reported nocturia may correlate with QoL."

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

Patients' experience with and perspectives on long-term use of continuous subcutaneous infusion of foslevodopa/foscarbidopa in Parkinson's disease. (PubMed, J Neurol) - P3 | "PwP expressed high satisfaction and willingness to continue using LDp/CDp. PwP and their care partners developed innovative strategies to integrate the pump into daily routines, and the perceived symptom improvement drove successful persistence on this well-tolerated treatment."

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

Efficacy and Safety of Novel Continuous Subcutaneous Levodopa Infusion Therapies ND0612 and ABBV-951 for Parkinson's Disease: A Systematic Review. (PubMed, J Geriatr Psychiatry Neurol) - "Infusions-site reactions were the main adverse event recorded.ConclusionsND0612 and ABBV-951 are promising options for enhancing motor control and quality of life in PD patients. However, further research is needed to assess long-term efficacy, safety, and comparisons with oral levodopa and device-aided treatments."

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

AAN 2025: Vyalev has good long-term safety profile in Parkinson’s (Parkinson's News Today) - P3 | N=130 | NCT04379050 | Sponsor: AbbVie | "Results from nearly two years of the extension study (NCT04379050) showed a safety profile generally consistent with that observed in the parent study, although with some differences in falls and injection-site reaction frequency.....These findings...[were]...presented at the American Academy of Neurology (AAN) annual meeting....The interim analysis presented at the conference showed that after 96 weeks, Vyalev’s safety was generally similar to that reported in the parent study, with 92.2% of the patients experiencing at least one adverse event, leading to treatment discontinuation in 10.1%. Falls were more frequent in the extension study than in the parent trial (32.6% vs. 16.8%), while patients less frequently experienced infusion site reactions like skin redness (22.5% vs. 52%) and skin infection (18.6% vs. 23%)."

P3 data • Parkinson's Disease

Foslevodopa/Foscarbidopa: A Review in Advanced Parkinson's Disease. (PubMed, CNS Drugs) - "Foslevodopa/foscarbidopa [PRODUODOPA® (EU); VYALEV™ (USA, Canada, Japan)] is a soluble formulation of levodopa and carbidopa prodrugs for 24-h continuous subcutaneous (SC) infusion. However, infusion site events were common, necessitating regular monitoring, cannula replacement, infusion site rotation and aseptic techniques. Although further long-term data are required, foslevodopa/foscarbidopa represents a promising non-surgical alternative to the available device-aided therapies for patients with advanced PD whose motor fluctuations are inadequately controlled by other oral PD medications."

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

The Safety and Efficacy of Subcutaneous Forms of Levodopa/Carbidopa (ND0612 and Foslevodopa/Foscarbidopa) on Parkinson's Disease Patients: Systematic Review and Meta Analysis (P11-5.030). (PubMed, Neurology) - "We searched six different databases for RCTs and single arm studies until November 2024 to screen included studies talking about Subcutaneous forms of levodopa/carbidopa such as subcutaneous levodopa/carbidopa known as ND0612 and Foslevodopa/Foscarbidopa known as ABBV-951...Dr. Saha has nothing to disclose."

Clinical • Journal • Retrospective data • Review • CNS Disorders • Dermatology • Mood Disorders • Movement Disorders • Pain • Parkinson's Disease • Psychiatry

Sustained Long-term Safety and Tolerability of Foslevodopa/Foscarbidopa in Parkinson's Disease: 96-week Primary Treatment Period Results from an Ongoing Open-label Extension Study (P11-5.006). (PubMed, Neurology) - P3 | "Fung has received publishing royalties from a publication relating to health care. Disclaimer: Abstracts were not reviewed by Neurology® and do not reflect the views of Neurology® editors or staff."

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

Improvement of Troublesome Dyskinesia in People with Parkinson's Disease Treated with Foslevodopa/Foscarbidopa (AAN 2025) - P3 | "Continuous delivery of LDp/CDp was associated with significant improvements in dyskinesia and quality of life in patients with relevant/significant troublesome dyskinesia at baseline."

CNS Disorders • Movement Disorders • Parkinson's Disease