Summary

This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

• 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).