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A new drug application has been resubmitted to the Food and Drug Administration (FDA) for istradefylline (KW-6002; Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan). Istradefylline has been investigated as an adjunctive treatment to levodopa/carbidopa for Parkinson’s disease OFF symptoms.
Istradefylline is an investigational, selective adenosine A2A receptor antagonist approved in Japan for the adjunctive treatment of the wearing-off phenomenon but has no approved indication in the US. “Istradefylline is an A2A receptor antagonist, and if approved by FDA, may provide a novel, nondopaminergic, pharmacologic approach to treating ‘off’ episodes for people living with PD,” said Stuart Isaacson, MD, director, Parkinson’s Disease and Movement Disorders Center of Boca Raton.
Peter McAllister, MD
Janel Schneider, MD
Mathew R. Ayers, DO; Diana Svaldi, PhD; and Liana G. Apostolova, MD, MS