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This approval makes foscarbidopa/foslevodopa the first and only subcutaneous 24-hour infusion of levodopa-based therapy for adults with Parkinson disease.
Updated: October 17, 2024 at 10:57 AM.
The FDA approved foscarbidopa/foslevodopa (Vyalev; AbbVie) for the treatment of motor fluctuations in adults who have advanced Parkinson disease (PD). This treatment is the first and only subcutaneous 24-hour infusion of a levodopa-based therapy for those with PD, and the approval was supported by results from a phase 3 clinical trial (NCT04380142) in which foscarbidopa/foslevodopa demonstrated safety, efficacy, and improvements in motor fluctuations.1
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Trial Name: Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's Disease
ClinicalTrials.gov ID: NCT04380142
Sponsor: AbbVie
Completion Date: September 29, 2021
Foscarbidopa/foslevodopa is a solution of carbidopa and levodopa prodrugs intended for 24-hour continuous subcutaneous infusion for the treatment of motor fluctuations in adults with advanced PD. Over 10 million people worldwide are living with PD, which is a progressive neurological disorder that is characterized by tremors, muscle rigidity, slowness of movement, and difficulty balancing. These symptoms being when approximately 60% to 80% of the cells in the brain that produce dopamine continue to worsen slowly over time. Currently, there is no cure for PD, but there are treatments available—such as the newly FDA-approved foscarbidopa/foslevodopa—that can help reduce patients’ symptoms.1
Foscarbidopa/foslevodopa was evaluated in a randomized, double-blind, double-dummy, active-controlled phase 3 study to compare the efficacy, safety, and tolerability of thew treatment to oral carbidopa/levodopa in patients with advanced PD. A total of 141 patients were randomly assigned to receive either continuous subcutaneous infusion of foscarbidopa/foslevodopa and oral placebo (n = 74), or oral carbidopa/levodopa with continuous subcutaneous infusion of placebo (n = 67) for a 12-week duration.1,2
Further, participants were instructed to monitor their motor state during the day using a home diary. The primary end point was a good “on” time—which was defined as a state where symptoms are well-controlled and without involuntary movements (dyskinesia)—and this was collected and averaged over 3 consecutive days, then normalized to a typical 16-hour waking period. Baseline values were defined as the average of normalized good “on” time that was collected over the 3 PD diary days prior to randomization. Additionally, safety and tolerability outcomes were also assessed throughout the study.1-3
The findings indicated that foscarbidopa/foslevodopa showed a significantly greater increase in “on” time without any troublesome dyskinesia (2.72 [0.52] vs 0.97 [0.50] hours; difference: 1.75 hours; 95% CI 0.46 to 3.05; p = .0083), and a significantly greater reduction in “off” time (−2.75 [0.50] vs −0.96 [0.49] hours; difference: −1.79 hours, −3.03 to −0.54; p = .0054) compared with the carbidopa/levodopa regimen. Additionally, the investigators observed improvements in “on” time as early as week 1, and these persisted throughout the 12-week duration.1,3
"For too long, the PD 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, MD, MBA, professor of neurology, director of the Parkinson's and Movement Disorder Center, University of South Florida, in a news release. “This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night.”1
Further, adverse events (AEs) were reported by approximately 85% (n = 63) of patients who received foslevodopa/foscarbidopa compared with 63% (n = 42) of those who received carbidopa/levodopa. The rate of serious AEs were similar between the 2 groups, with foslevodopa/foscarbidopa reporting 6 (8%) and carbidopa/levodopa reporting 4 (6%). In the foslevodopa/foscarbidopa group, the most common AEs were infusion site AEs such as erythema (n = 20; 27%), pain (n = 19; 26%), cellulitis (n = 14; 19%), and oedema (n = 9; 12%), of which most were mild to moderate in severity. Additionally, AEs led to premature discontinuation of the study drug in about 22% (n = 16) of participants in the foslevodopa/foscarbidopa group versus 1% (n = 1) in the carbidopa/levodopa.3
“People living with advanced PD experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses,” said Roopal Thakkar, MD, executive vice president, research & development, and chief scientific officer, AbbVie, in the news release. “We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of [foscarbidopa/foslevodopa].”1
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