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News From the Food and Drug Administration
October 1, 2019

Add-on Drug Approved for “Off” Episodes of Parkinson Disease

JAMA. 2019;322(13):1246. doi:10.1001/jama.2019.15403

Istradefylline tablets have received FDA approval as an add-on treatment to levodopa and carbidopa for adults with Parkinson disease during “off” episodes when symptoms increase because medications aren’t working well. The drug has been marketed in Japan since 2013 as adjunctive therapy for Parkinson disease.

Marketed as Nourianz, istradefylline is a selective adenosine A2A receptor antagonist that boosts dopamine signaling, which is deficient in the brain when patients have Parkinson disease. The drug’s efficacy was shown in four 12-week clinical trials involving 1143 patients. In each study, participants who received istradefylline had a statistically significant decrease in daily off time compared with those who received a placebo. The most common adverse reactions were dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia.