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Safinamide Phase III Study Results Presented at 2013 MDS Meeting
Date:6/18/2013

ate. In addition, safinamide shows a very rapid onset of efficacy with significant improvements being observed in ON-time (p=0.0003) and OFF-time (p<.0001) from week two onwards. These results will be part of the regulatory submission planned to be filed in Europe and USA in QIV/2013."

"The responder rate analysis using multiple and combined criteria show compelling evidence that a substantial proportion of Parkinson's disease patients, even in advanced stage treated with safinamide obtain significant clinical benefits in all major motor symptoms thus significantly improving their quality of life", said Marco Sardina, Zambon's CSO.

SETTLE study was a six-month (24-week), randomized, double-blind, placebo-controlled international Phase III trial. It enrolled 549 patients with mid-to late-stage idiopathic Parkinson's disease (more than three years of disease duration) treated with optimized, stable doses of levodopa and standard of care (dopamine agonist, COMT inhibitor, anticholinergic and/or amantadine) for at least four weeks. Patients who were experiencing a minimum of one and a half hours of "OFF" time during the day were randomized equally to treatment with once a day safinamide (50-100mg) or placebo (standard of care including levodopa), as adjunctive treatment. Based on discussions with the regulatory authorities, the primary endpoint of the trial was the change in daily "ON" time, as assessed by the patient completed daily diary cards (18 hours/day).

Safinamide was very well tolerated. 484 patients completed the trial; the drop-out rate was similar in both treatment groups (approx. 12%). The most commonly reported adverse events were nausea, urinary tract infections, falls, back pain and dyskinesia. Transient dyskinesia occurred more frequently with safinamide, but was mainly mild, and was not associated with treatment discontinuation. Similarly, the incid
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