Safinamide

(Xadago®)

Safinamide

Drug updated on 12/11/2024

Dosage FormTablet (oral; 50 mg, 100 mg)
Drug ClassMonoamine 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.

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Summary
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  • 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 TitleYearSource
Xadago (safinamide) Prescribing Information.2021MDD US Operations, LLC., Rockville, MD

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Effects of Safinamide on Motor and Non-Motor Symptoms in Patients with Parkinson's Disease and Motor Fluctuations2024European Neurology
Efficacy and Safety of MAO-B Inhibitors Safinamide and Zonisamide in Parkinson's Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials2023CNS Drugs
Comparative efficacy and safety of monoamine oxidase type B inhibitors plus channel blockers and monoamine oxidase type B inhibitors as adjuvant therapy to levodopa in the treatment of Parkinson's disease: a network meta-analysis of randomized controlled trials2023European Journal of Neurology
The Efficacy of Safinamide in the Management of Parkinson's Disease: A Systematic Review2022Cureus
Effects of MAO-B inhibitors on non-motor symptoms and quality of life in Parkinson's disease: A systematic review2022NPJ Parkinson’s Disease
How to Optimize the Effectiveness and Safety of Parkinson's Disease Therapy? - A Systematic Review of Drugs Interactions with Food and Dietary Supplements2022Current Neuropharmacology
Systematic Review on Parkinson's Disease Medications, Emphasizing on Three Recently Approved Drugs to Control Parkinson's Symptoms2021International Journal of Environmental Research and Public Health
Overall Efficacy and Safety of Safinamide in Parkinson's Disease: A Systematic Review and a Meta-analysis2021Clinical Drug Investigation
A systematic review and meta-analysis of safety and efficacy of safinamide for motor fluctuations in patients with Parkinson's disease2019F1000Research

Clinical Practice Guidelines