Drug updated on 12/11/2024
Dosage Form | Tablet (oral; 50 mg, 100 mg) |
Drug Class | Monoamine oxidase type B (MAO-B) Inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinsons disease (PD) experiencing off episodes.
Latest News
Summary
- This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
- Safinamide at 100 mg/day and 50 mg/day significantly improved on-time without troublesome dyskinesia (mean difference (MD): -0.90 h; 95% confidence interval (CI) -1.12 to -0.67 and MD: -0.77 h; 95% CI -1.21 to -0.34, respectively) and reduced off-time (MD: -0.94 h; 95% CI -1.19 to -0.70 and MD: -0.72 h; 95% CI -1.03 to -0.41) compared to placebo.
- Safinamide significantly improved motor scores (UPDRS-III), with reductions of -3.01 (95% CI -4.15 to -1.86) for 100 mg/day and -2.93 (95% CI -5.14 to -0.71) for 50 mg/day, and also improved mood and quality of life measures (Parkinson's Disease Questionnaire-39 (PDQ-39) and GRID Hamilton Rating Scale for Depression (GRID-HAMD)).
- In Parkinson's disease patients with motor fluctuations (PDwMF), safinamide was more effective at reducing symptoms compared to placebo at both 100 mg and 50 mg doses, while the effect was less pronounced in patients without motor fluctuations (PDwoMF).
- Safinamide showed no significant differences in the incidence of serious adverse events compared to placebo across all doses examined in Parkinson's disease patients.
- Rasagiline, in comparison, was associated with a higher incidence of adverse events compared to placebo and safinamide.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Xadago (safinamide) Prescribing Information. | 2021 | MDD US Operations, LLC., Rockville, MD |
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 |