Safinamide

(Xadago®)

Safinamide

Drug updated on 5/17/2024

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

Summary
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  • Safinamide (Xadago) is indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. It has been reported to manage motor fluctuations, pain, depression, and improve the quality of life for these patients.
  • The information was derived from seven systematic reviews/meta-analyses that focused on the effectiveness and safety of Safinamide compared to other medications used in treating Parkinson's Disease.
  • Among monoamine oxidase type B inhibitors (MAO-BIs), including selegiline, rasagiline, safinamide, and zonisamide, no significant difference was detected among them in improving Parkinson's symptoms. However, safinamide scored highly for its safety profile.
  • In terms of efficacy aspects beyond symptom control, it has shown superiority over istradefylline in controlling motor symptoms when used as an adjunct to levodopa according to one study.
  • While safinamide is effective at managing a wide range of Parkinson's disease symptoms, including non-motor ones, some studies have highlighted that its safety profile requires careful consideration due to potential adverse events which were not significantly different than those experienced by placebo groups according to one study reviewed.
  • Subgroup considerations suggest that benefits are especially pronounced among Parkinson's disease patients with motor fluctuations (PDwMF). This supports a personalized medicine approach where treatment can be tailored based on individual patient profiles.

Product Monograph / Prescribing Information

Document TitleYearSource
Xadago (Safinamide) Prescribing Information.2021US WorldMeds, LLC., Louisville, KY

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines