Safinamide (Xadago(®)) is an oral α-aminoamide derivative developed by Newron 
for the treatment of Parkinson's disease (PD). The drug has both dopaminergic 
properties (highly selective and reversible inhibition of monoamine oxidase-B) 
and non-dopaminergic properties (selective sodium channel blockade and calcium 
channel modulation, with consequent inhibition of excessive glutamate release). 
Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on 
therapy to stable-dose levodopa, alone or in combination with other PD therapies 
in mid- to late-stage fluctuating PD patients; regulatory submissions have also 
been filed in the USA and Switzerland for its use in this indication. Additional 
submissions have been made in the USA, Iceland, Lichtenstein, Norway and 
Switzerland for early-stage PD. Safinamide has also undergone phase II 
investigation in PD patients with drug-induced dyskinesia (France, Germany, 
Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This 
article summarizes the milestones in the development of safinamide leading to 
its first approval for PD.