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Investigators Update 2-Year Data on Safinamide Use in Parkinson’s Disease Patients

Authors

Christin Melton

Honolulu—A 2-year trial of patients with Parkinson’s disease (PD) and motor fluctuations found the addition of daily safinamide increased the amount of time each day in which patients experienced symptom relief with levodopa (ON time) and little to no dyskinesia. Safinamide is a novel agent being investigated as an adjunct therapy to dopamine agonists for patients with early PD and to levodopa for patients with mid- to late-stage PD. The oral drug has dopaminergic and nondopaminergic mechanisms of action, increasing dopamine levels through selective inhibition of monoamine oxidase (MAO)-B, dopamine reuptake, and glutamate release. In a 2-part investigation of safinamide use, consisting of a 6-month phase 3 clinical trial (Study 016) and an 18-month extension study (Study 018), investigators assessed the safety and efficacy of 50-mg and 100-mg daily doses of safinamide in patients with mid- to late-stage PD. Updated 24-month data were presented in a poster session at the AAN meeting. The poster was titled First Long-Term (2-year) Controlled Study to Evaluate Treatment with Safinamide as Add-on to Levodopa in Patients with Parkinson’s Disease and Motor Fluctuations. Study 016 included 669 patients aged 30 to 80 years with idiopathic PD (4 at baseline showed significant improvement in ON time DRS scores at 24 weeks with safinamide 100 mg versus placebo (P=.03). Patients in this subgroup assigned to safinamide 100 mg were more likely to have their levodopa dose decreased compared with patients randomized to safinamide 50 mg or placebo (15.8% vs 19.8% vs 26.3%, respectively). The authors noted that, overall, patients in the safinamide 100-mg group demonstrated greater improvement in motor function, non-motor symptoms such as depression and activities of daily living, and clinical status compared with patients in the other arms. At the end of Study 016, patients taking safinamide experienced an increase in the average amount of ON time each day with no/minor dyskinesia and a decrease in the average amount of OFF time compared with patients given placebo. This study was funded by Newron and Merck Serono S.A.-Geneva.

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