Produodopa (foscarbidopa/foslevodopa) / AbbVie - LARVOL DELTA

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

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 (AAN 2025) - P3 | "LDp/CDp showed favorable long-term safety/tolerability with sustained efficacy through OLES W96 (total treatment of 148W including the 52W parent study)."

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

Response to Foslevodopa/Foscarbidopa by Sex: Post Hoc Analyses of 2 Phase 3 Clinical Studies (AAN 2025) - P3 | "LDp/CDp improved motor fluctuations in both sexes, with potential differences warranting further investigation. AEs were mixed between the sexes. Real-world studies will be performed to evaluate potential sex differences further."

Clinical • P3 data • Retrospective data • CNS Disorders • Dermatology • Infectious Disease • Movement Disorders • Parkinson's Disease

Improvement in Morning Akinesia After Foslevodopa/Foscarbidopa Treatment was Associated with Significantly Improved Motor Fluctuations, Activities of Daily Living, and Quality of Life in People with Parkinson's Disease (AAN 2025) - P3 | "Patients receiving LDp/CDp who changed to waking in the "ON" state experienced: more "ON" Time and less "OFF" Time throughout the day, improved QoL, and increased ability to participate in ADL."

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

Vyalev - foscarbidopa/foslevodopa subcutaneous infusion for Parkinson's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Subcutaneous administration of foslevodopa/foscarbidopa (PRODUODOPA®) in arm and thigh due to giant epigastric hernia: a case report. (PubMed, Neurol Sci) - "PRODUODOPA can be administered subcutaneously in the area of ​​the upper and lower extremities with just as good results as after subcutaneous infusion in abdomen."

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

Cost-Effectiveness of Foslevodopa/Foscarbidopa for the Treatment of Advanced Parkinson's Disease With Severe Motor Fluctuations and Hyperkinesia or Dyskinesia in Greece (ISPOR-EU 2024) - P3 | "Foslevodopa/foscarbidopa was found to be a cost-effective treatment option versus LCIG for patients with advanced PD with severe motor fluctuations and hyperkinesia or dyskinesia in Greece."

Cost effectiveness • HEOR • Metastases • CNS Disorders • Movement Disorders • Parkinson's Disease

U.S. FDA Approves VYALEV (foscarbidopa and foslevodopa) for Adults Living with Advanced Parkinson's Disease (PRNewswire) - "AbbVie...today announced that the U.S. Food and Drug Administration (FDA) has approved VYALEV (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease (PD)...The approval was supported by the pivotal Phase 3, 12-week study evaluating the efficacy of continuous subcutaneous infusion of VYALEV in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR), along with a 52-week, open-label study which evaluated the long-term safety and efficacy of VYALEV...Timing for a patient's access to VYALEV is dependent on their individual insurance plan. Coverage for Medicare patients is expected in the second half of 2025."

FDA approval • Reimbursement • CNS Disorders • Parkinson's Disease

Continuous Subcutaneous Foslevodopa-Foscarbidopa in Parkinson's Disease: A Mini-Review of Current Scope and Future Outlook. (PubMed, Mov Disord Clin Pract) - "Foslevodopa-foscarbidopa emerges as a promising alternative for advanced PD treatment, offering sustained symptom control. Its efficacy in managing motor fluctuations and dyskinesia makes it a viable option in the PD therapeutic spectrum. Future research should focus on long-term safety, economic impact, and broader accessibility. Foslevodopa-foscarbidopa is now commercially distributed in many countries in Europe and in Japan."

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

Improvement of Troublesome Dyskinesia in People With Parkinson’s Disease Treated With Foslevodopa/Foscarbidopa (EAN 2024) - 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

Efficacy and safety of foslevodopa/foscarbidopa continuous subcutaneous infusion administered as monotherapy in patients with Parkinson’s disease (ATMRD 2024) - No abstract available.

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 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Jun 2025 ➔ Apr 2026 | Trial primary completion date: Jun 2025 ➔ Apr 2026

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

Integrated analysis of phase 3 trials of foslevodopa/foscarbidopa demonstrated that majority of reported infusion site AEs including infections were non serious, mild to moderate in severity and did not result in treatment discontinuation (ATMRD 2024) - No abstract available.

AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa) (PRNewswire) - "AbbVie...announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson's disease. In its letter, the FDA cited observations that were identified during inspection of a third-party manufacturer listed in the New Drug Application (NDA). The inspection at the facility did not involve ABBV-951 or any AbbVie medicine."

CRL • CNS Disorders • Parkinson's Disease

Effects of Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa on Sleep Dysfunction in People With Parkinson’s (ATMRD 2024) - No abstract available.

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 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: May 2025 ➔ Apr 2026 | Trial primary completion date: May 2025 ➔ Apr 2026

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

Effects of Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa on Sleep Dysfunction in People With Parkinson’s (IAPRD 2024) - No abstract available.

Investigational Pump Agents to Treat Parkinson Disease (NeurologyLive) - "In this segment, Kremens described pump therapies currently in development, such as ND0612 and ABBV-951."

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