Eisai, Meiji Seika's safinamide meets in Phase II/III for PD

Eisai Co. Ltd. (Tokyo:4523) and Meiji Seika Pharma Co. Ltd. (Tokyo, Japan) reported preliminary data from a Phase II/III trial in about 410 Parkinson's disease patients with wearing-off phenomenon showing that once-daily 50 and 100 mg oral safinamide (ME2125) as an add-on therapy to levodopa both met the primary endpoint of improving the change from baseline in mean daily "on" time at week 24 vs. placebo. This year, Meiji plans to submit an MAA in Japan for safinamide.

The double-blind, Japanese trial's secondary endpoints include "off" time, Unified PD Rating Scale (UPDRS), 39-item PD Questionnaire (PDQ-39), responder rate and safety...