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Safinamide is a Parkinson disease (PD) medication that acts on the dopaminergic and non-dopaminergic systems. The mechanisms of action include making dopamine more available by blocking the enzyme monoamine oxidase B (MAO-B), blocking sodium and potassium channels, and reducing glutamate release. Safinamide is not currently FDA approved (but other MAO-B drugs are).
In this double-blind, manufacturer-supported phase III study, investigators compared safinamide to placebo in 549 PD patients already on levodopa therapy and experiencing >1.5 hours per day of off time. Off time was defined as the patient perception that PD medications failed to kick in and was measured by a validated diary. PD drug regimens were optimized and held stable for 1 mo…