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Istradefylline

(Nourianz®)

Nourianz®

Drug updated on 12/11/2024

Dosage FormTablet (oral; 20 mg, 40 mg)
Drug ClassAdenosine receptor antagonists
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • ndicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "off" episodes.

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Istradefylline demonstrated significant improvement in motor symptoms in Parkinson's Disease (PD) patients, evidenced by a reduction in OFF time (-0.58 [-1.01 to -0.16]; p = 0.007) and improvement in ON state with dyskinesia (0.69 [0.02 to 1.37]; p = 0.043), as well as a mean difference of -0.70 in OFF time duration (95% confidence interval (CI) [-1.11, -0.30]; P < 0.001) and a mean difference (MD) of -1.56 in the Unified Parkinson's Disease Rating Scale (UPDRS) II (95% CI [-2.71, -0.40]; P < .008) in various studies.
  • In pooled analyses of eight randomized controlled trials, istradefylline reduced OFF hours/day at doses of 20 mg/day (least-squares mean difference (LSMD) = -0.38 h [-0.61, -0.15]) and 40 mg/day (-0.45 h [-0.68, -0.22], p < 0.0001), while increasing ON time without troublesome dyskinesia.
  • When compared to other drugs, istradefylline was found to be less effective than safinamide, which showed significant improvements in UPDRS part III scores at both 50 mg (p = 0.0138) and 100 mg (p = 0.0006) doses, although it was superior to opicapone in improving UPDRS III scores (MD = -1.56 vs. opicapone MD = -0.63; P < 0.008).
  • Istradefylline exhibited no significant difference in adverse effects compared to placebo, with treatment-emergent adverse events (TEAEs) reported at a relative risk (RR) of 1.11. Dyskinesia incidence was higher with istradefylline (RR = 1.77) compared to opicapone (RR = 3.47), which showed greater prevalence of this adverse event.
  • Dyskinesia was the most frequent adverse event associated with istradefylline, occurring in 9.6% of patients on placebo, 16.1% at a dose of 20 mg/day, and 17.7% at a dose of 40 mg/day. The average study completion rate for istradefylline among treated patients was 89.2%.
  • There is no population types or subgroups information available in the reviewed studies.