NOURIANZ

Istradefylline exhibits dose-proportional pharmacokinetics after multiple oral doses from 20 mg to 80 mg (2 times the maximum recommended dosage). Steady-state was reached within 2 weeks of once-daily dosing. The pharmacokinetics of istradefylline were similar in PD patients and healthy subjects.

AbsorptionThe median time to reach the maximum concentration (T max ) for istradefylline was about 4 hours under fasted dosing conditions. Effect of Food Istradefylline exposure, represented by the are...

The efficacy of NOURIANZ for the adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes was shown in four randomized, multicenter, double-blind, 12-week, placebo-controlled studies (

Study 1NCT00456586;

Study 2NCT00199407;

Study 3NCT00455507; and

Study 4NCT00955526). The studies enrolled patients with a mean duration of Parkinson's disease of 9 years (range: 1 month to 37 years) that were Hoehn and Yahr Stage II to IV, experiencing at least 2 hours (mean approximately 6 hours) of "off" time per day, and were treated with levodopa for ...

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Dyskinesia [see Warnings and Precautions (5.1) ] Hallucinations / Psychotic Behavior [see Warnings and Precautions (5.2) ] Impulse Control / Compulsive Behaviors [see Warnings and Precautions (5.3) ] The most common adverse reactions (at least 5% and more frequent than placebo) were dyskinesia, dizziness, constipation, nausea, hallucination, and insomnia ( 6.1 ). To report SU...

None. None ( 4 ).

Dyskinesia: Monitor patients for dyskinesia or exacerbation of existing dyskinesia ( 5.1 ). Hallucinations / Psychotic Behavior: Consider dosage reduction or stopping NOURIANZ if occurs ( 5.2 ). Impulse Control / Compulsive Behaviors: Consider dosage reduction or stopping NOURIANZ if occurs ( 5.3 ). 5.1 Dyskinesia NOURIANZ in combination with levodopa may cause dyskinesia or exacerbate pre-existing dyskinesia. In controlled clinical trials (Studies 1, 2, 3, and 4) [see Clinical Studies (14) ] , ...

7 DRUG INTERACTIONS Strong CYP3A4 inhibitors: Recommended maximum dosage with concomitant use is 20 mg once daily ( 2.2 , 7.1 ). Strong CYP3A4 inducers: Avoid use ( 2.3 , 7.1 ). 7.1 Effect of Other Drugs on NOURIANZ Strong CYP3A4 Inhibitors Coadministration of NOURIANZ with a strong CYP3A4 inhibitor (ketoconazole) increased istradefylline AUC inf by 2.5-fold [see Clinical Pharmacology (12.3) ] . T...