Safinamide (Xadago®) is an orally active, selective, reversible monoamine 
oxidase-B inhibitor with both dopaminergic and non-dopaminergic (glutamatergic) 
properties. In the EU, safinamide is approved for the treatment of mid- to 
late-stage fluctuating Parkinson's disease (PD) as add-on therapy to a stable 
dose of levodopa alone or in combination with other PD 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 PD 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 PD medications in patients with mid- to late-stage 
PD experiencing motor fluctuations.