Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 50 mg, 100 mg) |
Drug Class | Monoamine oxidase type B Inhibitor |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.
Latest News
Summary
- Xadago (safinamide) is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “off” episodes.
- This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
- Safinamide significantly improved UPDRS III scores compared to levodopa monotherapy, with a mean difference of 2.67 (95% CI: 1.45-3.87). Safinamide 100 mg was the most effective in improving these scores, showing notable improvement in UPDRS III in comparison to placebo.
- Safinamide demonstrated effectiveness in managing motor fluctuations, increasing ON-time without troublesome dyskinesia by a mean difference of 0.95 hours (95% CI: 0.41-1.49) and reducing OFF-time by a mean difference of -1.06 hours (95% CI: -1.60 to -0.51).
- Safinamide was less effective as monotherapy compared to dopamine agonists and other MAO-B inhibitors in combination with levodopa, though it showed a comparable safety profile and was associated with improvements in UPDRS-II and PDQ-39 outcomes without significant increases in adverse events.
- Safinamide did not show a higher incidence of adverse events compared to placebo and may have a safer profile than conventional MAO-B inhibitors, with no significant increase in adverse events associated with its use.
- A pooled meta-analysis indicated that safinamide had a comparable safety profile to placebo, and rasagiline showed a higher incidence of adverse events compared to safinamide and placebo, with no significant safety concerns noted for safinamide compared to other MAO-B inhibitors.
- Safinamide demonstrated significant improvement in ON-time without troublesome dyskinesia and reduction in OFF-time in Parkinson’s Disease patients with motor fluctuations (PDwMF), particularly with doses of 50 mg and 100 mg; however, it showed limited efficacy in improving UPDRS-III scores in patients without motor fluctuations (PDwoMF).
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Xadago (Safinamide) Prescribing Information. | 2021 | US WorldMeds, LLC., Louisville, KY |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
A Spanish consensus on the use of safinamide for Parkinson’s disease in clinical practice. | 2020 | Brain Sciences |
Current status of pain management in Parkinson's disease. | 2020 | Canadian Neurosurgical Society |