Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Piv... ( GENEVA Feb. 3 /- -- The Si...)

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Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial

Date:2/3/2009

GENEVA, Feb. 3 /PRNewswire/ --

-- The Six-Month Primary Efficacy Endpoint of the Study was met: Both Doses of Investigational Agent Safinamide Significantly Increased "ON" Time in Levodopa-Treated Patients With mid- to Late-Stage Parkinson's Disease

-- Secondary Efficacy Endpoints of the Study Analyzed to Date Were met in Both Safinamide Dose Groups

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, and its partner Newron Pharmaceuticals SpA (SWX: NWRN), announced today that the first Phase III trial of investigational agent safinamide as adjunctive therapy to levodopa (study 016) met its primary endpoint by increasing daily "ON" time in mid- to late-stage Parkinson's disease patients with motor fluctuations by 1.3 hours. "ON" time represents periods when Parkinson's patients experience their best level of motor functioning.

The two safinamide treatment groups of the study (receiving either safinamide 50 mg orally once daily or safinamide 100 mg orally once daily as adjunctive therapy to levodopa) demonstrated a statistically significant increase of daily total "ON" time compared to placebo. Throughout the six months of the study, patients treated with both doses of safinamide experienced an average increase of "ON" time of 1.3 hours per day compared to baseline. Patients in the placebo group (receiving placebo in addition to levodopa and other anti-Parkinson therapies) reported an average increase of daily "ON" time of 0.7 hour compared to baseline. The differences between both safinamide dose groups and placebo were statistically significant with p-values of 0.008 (safinamide 50 mg daily) and 0.005 (safinamide 100 mg daily).

"The results indicate that safinamide, when used adjunctively to existing dopaminergic therapies for study patients in mid-to-late stages of Parkinson's disease, increases daily "ON" time of motor functioning," said Dr. Bernhar
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