Safinamide ( Xadago ) is an orally active, selective, reversible monoamine oxidase-B inhibitor with both dopaminergic and non-dopaminergic ( glutamatergic ) properties.

In the European Union, Safinamide is approved for the treatment of mid- to late-stage fluctuating Parkinson's disease as add-on therapy to a stable dose of Levodopa alone or in combination with other medications.

Safinamide 50-100 mg/day administered as a fixed or flexible dose significantly increased daily ON time without dyskinesia ( primary endpoint ) in patients with mid- to late-stage Parkinson disease with motor fluctuations in 24-week, placebo-controlled clinical trials.

Other outcomes, including motor function, overall clinical status and health-related quality of life, were also generally improved with Safinamide.

Furthermore, in an 18-month extension of one study, although dyskinesia ( primary endpoint ) was not significantly improved with Safinamide relative to placebo, treatment benefits in other outcomes were generally sustained over 24 months of treatment.

Safinamide was generally well tolerated in clinical trials; dyskinesia was the most common adverse event.

Although further studies are needed, including comparative and long-term studies, current evidence indicates that Safinamide extends the treatment options available for use as add-on therapy to Levodopa and other medications in patients with mid- to late-stage Parkinson disease experiencing motor fluctuations. ( Xagena )

Blair HA, Dhillon S, CNS Drugs 2017;31: 169-176

XagenaMedicine2017