Safinamide (formerly PNU-151774E) (Newron Pharmaceuticals) is a sodium and calcium channel modulator, which also inhibits MAO-B. Pharmacokinetics of enteric safi-namide is linear and proportionally related to the administered doses. The absorption of safinamide is rapid and the T1/2 is about 22 hours. Safinamide reversibly and specifically inhibits the MAO-B enzyme. No evidence of MAO-A inhibition was observed even at the highest single dose of 10mg/kg (23).
A three-month controlled trial of safinamide in de novo and dopamine agonist treated patients was conducted (24). A median safinamide dose of 70 mg/day (range 40-90 mg/day) increased the percentage of parkinsonian patients that improved their motor scores by 30% compared to placebo (37.5% vs. 21.4%, P < 0.05). In a subgroup of 101 patients under stable treatment with a single dopamine agonist, addition of safinamide magnified the response (47.1% responders, mean 4.7-point motor score decrease; P = 0.05).
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