Drug updated on 9/4/2024
| Dosage Form | Tablet (oral; 20 mg, 40 mg) |
| Drug Class | Adenosine receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "off" episodes.
Latest News
Summary
- Nourianz (istradefylline) is indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "off" episodes.
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Motor Symptoms in Parkinson's Disease (PD) Population: Istradefylline significantly reduced OFF time (ranging from -0.58 to -0.85 units/hours/day, p < 0.0001) and improved ON time with dyskinesia (0.69 units, p=0.043). It also improved UPDRS III scores in some studies (MD = -1.56, p = 0.008), although it was less effective compared to safinamide, which significantly improved UPDRS III scores at 50 mg (p=0.0138) and 100 mg (p=0.0006) doses.
- Comparative Effectiveness: Safinamide showed superior efficacy compared to istradefylline in improving UPDRS III scores in PD patients with motor fluctuations. Both istradefylline and opicapone effectively reduced OFF time, but istradefylline additionally improved UPDRS III scores (MD = -1.56, p = 0.008), while opicapone did not (MD = -0.63, p = 0.12).
- PD Population and Subgroup Considerations: The studies focused on PD patients experiencing motor fluctuations and OFF episodes while on levodopa. There were no significant subgroup differences reported in the effectiveness across the studies.
- There was no significant difference in the incidence of treatment-emergent adverse events (TEAEs) between istradefylline and placebo. Dyskinesia was the most frequently reported adverse event for istradefylline, with higher rates observed at 40 mg/day (17.7%) compared to 20 mg/day (16.1%) and placebo (9.6%).
- Safinamide was considered safer than istradefylline, though specific safety data for istradefylline was not provided. Both istradefylline and opicapone had higher incidences of TEAEs compared to placebo, with dyskinesia being more frequent in opicapone (RR = 3.47) than in istradefylline (RR = 1.77).
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Nourianz (istradefylline) Prescribing Information. | 2023 | Kyowa Kirin Inc., Bedminster, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Efficacy and safety of istradefylline for parkinson’s disease: a systematic review and meta-analysis. | 2022 | Neuroscience Letters |
| Systematic review on parkinson's disease medications, emphasizing on three recently approved drugs to control parkinson's symptoms. | 2022 | International Journal of Environmental Research and Public Health |
| Istradefylline versus opicapone for “off” episodes in parkinson’s disease: a systematic review and meta-analysis. | 2021 | Annals of Neurosciences |
| Efficacy of istradefylline, an adenosine A2A receptor antagonist, as adjunctive therapy to levodopa in parkinson's disease: a pooled analysis of 8 phase 2b/3 trials. | 2021 | Journal of Parkinson’s Disease |