Zambon — Xadago EMA EPAR public assessment report (EMEA/H/C/002396, 2015)
Zambon · 2015 · EMA EPAR public assessment report
Report summary
This report summarizes the administrative, scientific, and clinical data for Xadago (safinamide) for Parkinson's disease. Safinamide, a reversible MAO-B inhibitor with additional neuroprotective properties, demonstrated efficacy in late-stage PD patients as an add-on to L-dopa, improving "ON-time" without troublesome dyskinesia. Its use in early PD was not robustly established. Pharmacokinetic studies showed high bioavailability and extensive metabolism. Preclinical toxicology revealed CNS, hepatic, and retinal effects at high doses, but these were generally not observed at therapeutic human doses. Safety data indicated a comparable profile to placebo, with some dose-dependent adverse events and a higher risk of dyskinesia in advanced patients. The CHMP recommended marketing authorization for safinamide as an add-on to levodopa for mid-to-late stage fluctuating PD patients.
Key findings — cited to the page
| first in man Phase I study | September 1999 | · p.35 |
| exploratory Phase II randomised placebo-controlled study in early PD | 2001 | · p.35 |
| Therapeutic indication | treatment of adult patients with idiopathic Parkinson’s disease (PD) as 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 | · p.2 |
| Product name | Xadago | · p.2 |
| Active substance | safinamide methanesulfonate | · p.2 |
| Strengths | 50 mg and 100 mg | · p.2 |
| Route of administration | Oral use | · p.2 |
| CHMP positive opinion date | 18 December 2014 | · p.11 |
| Proposed indication | The treatment of patients with idiopathic Parkinson’s disease (PD) as add-on therapy to: A single DA-agonist at a stable dose in early stage non-fluctuating patients, and A stable dose of L-dopa alone or in combination with other PD medications in mid- to late-stage fluctuating patients | · p.9 |
| UPDRS III mean (SFNM100) | 21.3 | STUDY 016 · p.72 |
| Pharmaceutical form | Film-coated tablet | · p.2 |
| rights acquisition | Merck Serono acquired the rights | safinamide · p.35 |
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