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This article is from NEJM Journal Watch
Subcutaneous Foslevodopa-Foscarbidopa for Advanced Parkinson Disease
Subcutaneous infusion of foslevodopa-foscarbidopa for advanced Parkinson's disease
Reviewed by Michael S.
Okun, MD
Compared with oral levodopa-carbidopa, continuous subcutaneous infusion of foslevodopa-foscarbidopa significantly improved daily "on" and "off" times
.
in patients with advanced Parkinson's disease (PD).
。 To evaluate the safety and efficacy of this therapy, investigators in the United States and Australia conducted an industry-funded multicenter, randomized, double-blind, double-mimicry, active-drug-controlled Phase 3 study that divided 141 patients with advanced PD (mean daily "off" time ≥ 2.
5 hours) into two groups, one with continuous subcutaneous infusion of foslevodopa-foscarbidopa and oral placebo, and the other with continuous subcutaneous infusion with placebo and oral levodopa-carbidopa
。
After 12 weeks of treatment, there was a significantly larger increase in mean 'opening' time in patients with continuous subcutaneous foslevodopa-foscarbidopa infusion without bothersome dyskinesia compared with those with oral levodopa-carbidopa (primary outcome; 2.
72 hours vs.
0.
97 hours/day; P=0.
0083), with a significantly larger reduction in mean "off" time (2.
75 hours/day vs.
0.
96 hours/day; P=0.
0054）
。 The most common adverse events (mostly mild to moderate) in the Foslevodopa-Foscarbidopa group were redness at the infusion site (27%), pain (26%), cellulitis (19%), and edema (12%); One patient developed catheter site cellulitis and one patient developed infusion site cellulitis
.
comments
The field has long been waiting for levodopa and carbidopa prodrugs
that can be infused subcutaneously.
If approved by the US FDA, the therapy would add a new treatment option for patients with Parkinson's disease that could be considered
before adopting more invasive therapies such as duodenal catheterization with a Dodopa pump, deep brain stimulation, or brain ablation.
Articles that were commented on
Soileau MJ 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; 21:1099.
(https://doi.
org/10.
1016/S1474-4422(22)00400-8)
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.
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