CAMBRIDGE, Mass., Nov. 09, 2016 (GLOBE NEWSWIRE) -- CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD) today reported financial and operating results for the quarter ended September 30, 2016.
Corporate Highlights
In September 2016 CoLucid announced that it had completed its first pivotal Phase 3 clinical trial of lasmiditan oral tablets, SAMURAI, which was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. Both the 100 mg and 200 mg doses of lasmiditan were efficacious on migraine headache pain freedom, the primary endpoint, and most bothersome associated symptom freedom, the key secondary endpoint, at the two-hour time point (p < 0.001). Both the primary and key secondary endpoints of SAMURAI conform to the U.S. Food and Drug Administration’s (“FDA”) draft Guidance for Industry, Migraine: Developing Drugs for Acute Treatment, issued in October 2014. Both the 100 mg and 200 mg doses of lasmiditan were also more efficacious than placebo on headache pain relief at the two-hour time point (p < 0.001), as a rescue medication on headache pain freedom at the two-hour time point (p < 0.001 and p < 0.012), in reducing migraine related disability at the two-hour time point (p < 0.001) and in improving Patient Global Impression of Change (p < 0.001). Lasmiditan was well tolerated with no significant difference in cardiovascular adverse events in patients dosed with lasmiditan versus placebo. SAMURAI is the first of two Phase 3 pivotal trials of lasmiditan, each being conducted under a Special Protocol Assessment (“SPA”) - agreement with the FDA.
