Safinamide: Extension study data

The 18-month, double-blind Phase III Study 018 extension study of the 6-month, double-blind, international Phase III Study 016 trial in 440 evaluable patients with mid- to late-stage idiopathic PD showed that once-daily 50 and 100 mg oral safinamide as an add-on to levodopa missed the primary endpoint of significantly improving mean DRS score from baseline to 24 months vs. placebo (0.19 and 0.28 points, respectively, vs. a 0.32 point worsening, p=0.21 and p=0.15). On secondary endpoints, low- and high-dose safinamide significantly increased mean daily "on" times without troublesome or minor dyskinesia from baseline to 24 months vs. placebo (1.01 and 1.18 hours, respectively, vs. 0.34 hours, p=0.0031 and p=0.002). High-dose safinamide also significantly improved UPDRS Parts II (activities of daily living), III (motor symptoms) and IV (complications of dopaminergic treatment) scores, symptoms of depression as measured by GRID-HAMD scores and quality of life as measured by PDQ-39 scores vs. placebo. ...