title: The safety and efficacy of safinamide mesylate for the treatment of Parkinson's disease.
abstract: Safinamide (brand name Xadago®, Zambon S.p.A) is a third-generation reversible MAO-B inhibitor, which also blocks sodium voltage-sensitive channels and modulates stimulated release of glutamate. Safinamide was recently licensed by EMA for the treatment of PD as add-on therapy to a stable dose of levodopa alone or in combination with other PD medicinal products in mid-to advanced-stage fluctuating patients. It is also under review by the US FDA. Studies in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP)-treated monkeys and 6OHDA-lesioned rats suggest antiparkinsonian efficacy and antidyskinesic effects. Randomized, double-blind, placebo-controlled trials have shown efficacy for the treatment of motor symptoms in stable PD patients on dopamine agonists and in fluctuating PD patients on levodopa. Significant improvement in daily ON time was also observed in the latter. This effect was maintained for at least 2 years in double-blind conditions and, interestingly, without significant worsening of dyskinesia. Clinical studies have not detected any specific safety issue other than those already known with MAO-B inhibitors.
authors: a Institute of Cardiologic Research, National Scientific and Research Council (ININCA-CONICET), Faculty of Medicine , University of Buenos Aires , Buenos Aires , Argentina.
authors: Santiago
authors: S
authors: Perez-Lloret
authors: b Department of Clinical Pharmacology and Neurosciences , NeuroToul Excellence Center for Neurodegenerative Disorders, University Hospital and University of Toulouse 3 , Toulouse , France.|c INSERM CIC1436 and UMR825 , Toulouse , France.|d NS-Park Network, INSERM , Toulouse , France.
authors: Olivier
authors: O
authors: Rascol
mesh_terms: D000409:Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D000818:Animals; D001596:Benzylamines / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D008996:Monoamine Oxidase Inhibitors / Q000009:adverse effects / Q000494:pharmacology*; D010300:Parkinson Disease / Q000188:drug therapy*
chemical_list: D001596:Benzylamines; D008996:Monoamine Oxidase Inhibitors; C092797:safinamide; D000409:Alanine
keywords: MAO-B inhibitors; Parkinson’s disease; antiparkinsonian treatment; dopamine agonists; dyskinesia; levodopa; motor fluctuations; safinamide