- VYALEV™ (also known as PRODUODOPA) is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson’s disease
- Adults treated with VYALEV reported superior improvement in “on” time without troublesome dyskinesia, compared to oral immediate-release carbidopa/levodopa1
- VYALEV allows for personalised dosing based on individual needs, morning, day and night
AbbVie announced on 17th October that the US 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 treatment is approved in 35 countries.
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)1, along with a 52-week, open-label study which evaluated the long-term safety and efficacy of VYALEV.2
“For too long, the Parkinson’s community has had limited treatment options for advanced disease. Due to the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required,” said Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson’s and Movement Disorder Center at the University of South Florida. “This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night.”
Findings from the pivotal study showed patients receiving VYALEV demonstrated superior improvement in motor fluctuations, with increased “on” time without troublesome dyskinesia and decreased “off” time, compared with oral CD/LD IR.1 “On” time refers to the periods of time when patients are experiencing optimal motor symptom control while “off” time is when symptoms return.3,4
The majority of adverse reactions (ARs) with VYALEV were non-serious and mild or moderate in severity. The most frequent ARs (greater than or equal to 10 percent and greater than CD/LD IR incidence) were infusion site events, hallucinations, and dyskinesia.1,2
“People living with advanced Parkinson’s disease experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses,” said Roopal Thakkar, M.D., Executive Vice President, Research & Development, and Chief Scientific Officer, AbbVie. “We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of VYALEV.”
PD is a progressive and chronic movement disorder resulting in tremor, muscle rigidity, slowness of movement and difficulty with balance resulting from the loss of dopamine-producing brain cells.5
Timing for a US patient’s access to VYALEV is dependent on their individual insurance plan. Coverage for Medicare patients is expected in the second half of 2025.
This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night
Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson’s and Movement Disorder Center at the University of South Florida
About the Phase 3 M15-736 Study1
The Phase 3 randomised, double-blind, double-dummy, active-controlled study compared the efficacy, safety and tolerability of VYALEV to oral CD/LD IR in patients with advanced PD. Participants were provided with a home diary (the PD Diary) to assess their motor state during the day. The primary endpoint of good “on” time (defined as “on” time without dyskinesia plus “on” time with non-troublesome dyskinesia), was collected and averaged over three consecutive days and normalised to a typical 16-hour waking period. Baseline values are defined as the average of normalised good “on” time collected over the three PD Diary days before randomisation. Approximately 130 adult participants with advanced PD were enrolled in the study across 80 sites in the U.S. and Australia. Participants were randomised 1:1 to receive either the VYALEV solution as a continuous delivery under the skin (subcutaneous) plus oral placebo capsules for CD/LD or oral capsules containing CD/LD IR plus continuous subcutaneous delivery of placebo solution for VYALEV. The treatment duration was 12 weeks. The increase in “on” time without troublesome dyskinesia at week 12 was 2.72 hours for VYALEV versus 0.97 hours for oral CD/LD IR (p=0.0083). Improvements in “on” time were observed as early as the first week and persisted throughout the 12 weeks. More information on the study can be found on http://www.clinicaltrials.gov (NCT04380142) and in The Lancet Neurology (https://doi.org/10.1016/S1474-4422(22)00400-8).
References
1 Soileau, M., et al. Safety and efficacy of continuous subcutaneous foslevodopa-foscarbidopa in patients with advanced Parkinson’s disease: a randomised, double-blind, active-controlled, phase 3 trial. Lancet Neurol. 2022 Dec;21(12):P1099-1109.
2 Aldred, J., et al. Continuous Subcutaneous Foslevodopa/Foscarbidopa in Parkinson’s Disease: Safety and Efficacy Results From a 12-Month, Single-Arm, Open-Label, Phase 3 Study. Neurol Ther. 2023 Dec;12(6):1937-1958.
3 “Motor fluctuations.” Parkinson’s Foundation. Available at: https://www.parkinson.org/library/fact-sheets/motor-fluctuations#:~:text=As%20levodopa%20begins%20to%20lose,are%20at%20their%20highest%20point. Accessed October 16, 2024.
4 “Off” Time in Parkinson’s Disease.” The Michael J. Fox Foundation for Parkinson’s Research. Available at: https://www.michaeljfox.org/time-parkinsons-disease. Accessed October 16, 2024.
5 “About Parkinson’s: Parkinson’s 101.” The Michael J. Fox Foundation for Parkinson’s Research. Available at: https://www.michaeljfox.org/understanding-parkinsons/i-have-got-what.php#q2. Accessed October 16, 2024.
6 “Statistics.” Parkinson’s Foundation. Available at: https://www.parkinson.org/understanding-parkinsons/statistics#:~:text=Nearly%2090%2C000%20people%20in%20the,worldwide%20are%20living%20with%20PD. Accessed October 16, 2024.
7 “Parkinson’s Disease: Hope Through Research.” National Institute of Neurological Disorders and Stroke. Available at: https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Hope-Through-Research/Parkinsons-Disease-Hope-Through-Research#:~:text=Loss%20of%20dopamine%20results%20in,by%20the%20time%20symptoms%20appear. Accessed October 16, 2024.
8 Freitas, ME., et al. Motor Complications of Dopaminergic Medications in Parkinson’s Disease. Semin Neurol. 2017;37(2):147-157.
