The European Commission has approved the use of Xadago ( Safinamide ) for the treatment of idiopathic Parkinson’s disease.
Xadago has been approved for mid-to late-stage fluctuating patients as add-on therapy to a stable dose of Levodopa ( L-dopa ) alone or in combination with other Parkinson medicinal products.
The decision follows the Positive Opinion adopted by the Committee for Medicinal Products for Human Use ( CHMP ) on December 18th, 2014 and is applicable to all 28 European Union member countries, as well as Iceland, Liechtenstein and Norway.
Levodopa, still the gold standard of symptomatic efficacy in the treatment of Parkinson's disease, in its long-term use is associated with motor complications.
Targeting non-dopaminergic systems might be an alternative approach to improve and control such motor complications, enhancing efficacy and removing the need for further increases in Levodopa dose, that has been shown to worsen motor fluctuations.
Xadago is the first add-on treatment for Parkinson disease showing both rapid onset of efficacy and improvements in ON and OFF time, without any increase in dyskinesia for at least two years, compared with standard of care, as demonstrated in a double-blind trial in patients receiving optimized treatment for Parkinson disease.
The Safinamide’s dual mechanism includes highly selective, reversible inhibition of MAO-B, and state and use-dependent blockade of sodium channels; the latter action leads to inhibition of stimulated release of glutamate. As excessive glutamate release is implicated in the etiology of dyskinesia, Safinamide could prevent or attenuate L-dopa induced dyskinesia in patients with Parkinson disease. ( Xagena )
Source: Zambon, 2015