Drug updated on 4/18/2024
| 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.
Summary
- Istradefylline (Nourianz) is indicated as an adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "off" episodes. It has shown a statistically significant difference in efficacy by improving motor symptoms and reducing "OFF" time.
- Four studies focused on the safety and efficacy of istradefylline compared to other drugs used for similar indications.
- The tolerability of istradefylline appears comparable to placebo, with an overall good safety profile. However, it does have higher rates of treatment-emergent adverse events (TEAEs) and incidence of dyskinesia than placebo groups.
- Compared to safinamide, istradefylline was found to be less efficacious but had fewer side effects such as dyskinesia.
- In comparison with opicapone, both drugs significantly reduced "off" time duration, but istradefylline showed better results in reducing Unified Parkinson's Disease Rating Scale part III scores, indicating its superior effectiveness over opicapone despite having a slightly higher incidence rate of dyskinesia.
- While specific subgroup considerations are not extensively detailed across the studies; they consistently focus on adult patients already being treated with levodopa/carbidopa but still experiencing "off" episodes, suggesting that these findings may be most applicable to advanced stages where individuals experience motor fluctuations despite optimized levodopa therapy.
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 |