A unique molecule with a novel dual mechanism of action based on the enhancement of the dopaminergic function (through potent reversible inhibition of MAO-B and of dopamine uptake) and reduction of glutamatergic activity by inhibiting glutamate release.
Results of a six month phase III trial (2006) as adjunctive treatment to dopamine agonists in early PD, demonstrated a positive effect in motor symptoms and activities of daily living, as well as an improvement in cognitive function while associated with good tolerability.
Recent results of the 12-month extension of the trial showed that the addition of safinamide to dopamine agonists does not cause any tolerability/safety risk when compared with dopamine agonist monotherapy. It also showed that, at a dose of 50 to 100 mg once daily, safinamide continues to provide sustained improvement of Parkinson’s disease motor symptoms and may delay the time to intervention for therapeutic adjustments.
In 2006, Newron signed an agreement with Serono (now Merck Serono) giving them exclusive worldwide rights to develop, manufacture and commercialise safinamide in Parkinson’s disease (PD), Alzheimer’s disease (AD), and other therapeutic indications.
For more details, see Partners.