Xadago

Xadago, with the active substance safinamide methanesulfonate, is a film-coated tablet available in 50 mg and 100 mg strengths for oral use. It is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as an add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients. A CHMP positive opinion was issued on 18 December 2014.

In clinical trials, safinamide 100 mg/day demonstrated an LS Mean Change in UPDRS-III-score (ON) at week 24 of -6.9. For daily ON time without troublesome dyskinesia, safinamide 50 mg/day showed a difference of 0.51 hours versus placebo, and safinamide 100 mg/day showed a difference of 0.55 hours versus placebo. Another study reported a difference of 0.96 hours for safinamide 100 mg/day versus placebo in daily ON time without troublesome dyskinesia. Safinamide also led to a decrease in OFF time of 0.5 hour (Study 016) and 1.00 hour (SETTLE study). Improvement in UPDRS II (ON phase) for safinamide 100 mg/day vs placebo was -2.2. The proportion of patients rated as improved on CGI-C was 66.4% for safinamide 50 mg/day and 64.3% for safinamide 100 mg/day, compared to 55.4% for placebo.

Safety findings include nervous system disorders incidence ranging from 27-33% in early-stage PD patients and 38-60% in late-stage PD patients. Gastro-intestinal disorders incidence was 22-29% (ESPD) and 22-27% (LSPD). Infections and infestations incidence was 19-29% (ESPD) and 18-22% (LSPD). Musculoskeletal disorders incidence was 19-24% (ESPD) and 20-30% (LSPD). Eye disorders incidence in LSPD patients was 16-27%. Safinamide also caused a 20% reduction in midazolam concentrations.