Produodopa (foscarbidopa/foslevodopa) / AbbVie - LARVOL DELTA

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."

Video

Metabolite profiling of foslevodopa/foscarbidopa in plasma of healthy human participants by LC-HRMS indicates no major differences compared to administration of levodopa/carbidopa intestinal gel. (PubMed, Pharmacol Res Perspect) - "Relative quantification of LC-MS peak areas showed no major differences in the metabolite profiles. These results indicate that neither the addition of monophosphate prodrug moieties nor SC administration affects the circulating metabolite profile of foslevodopa/foscarbidopa compared to LCIG."

Journal

Improvement of "On" and "Off" Times in Patients with Advanced Parkinson's Disease Treated with Foslevodopa/Foscarbidopa: Subgroup Analyses from a Phase 3 Randomized Study (AAN 2024) - P3 | "Patients experienced greater benefits with LDP/CDP vs oral LD/CD across all subgroups. No significant differences in treatment response were evident in any subgroup."

Clinical • Metastases • P3 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Long-term Safety and Tolerability of Foslevodopa/Foscarbidopa for Treatment of Motor Fluctuations in Parkinson's Disease (AAN 2024) - P3 | "Long-term LDp/CDp was generally safe and well tolerated. Treatment-related improvements in motor fluctuations, morning akinesia, and QoL observed at the conclusion of the 52-week parent study were maintained throughout the OLES."

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

Living with Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa for Symptom Management in Advanced Parkinson's Disease: A Patient Experience Study (AAN 2024) - P3 | "PwaPD had creative and effective strategies for using LDPp/CDp in their daily lives, including wearing the device during sleep or in social settings. Participants had an overall positive experience and acceptability of using the LDp/CDp delivery system for their aPD treatment."

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

Effects of Continuous Subcutaneous Infusion of Foslevodopa/Foscarbidopa on Sleep Dysfunction in People with Parkinson's (AAN 2024) - P3 | "These post hoc results demonstrate numerical improvement in two-of-three 12-week trial subdomains and TS in LDp/CDp versus oral (nominal P≤.001), and significant within-group improvements in all three subdomains and TS of the 12- and 52-week LDp/CDp ITT populations, suggesting CSCI of LDp/CDp improves sleep in PwP."

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