Oral lasmiditan: Additional Phase III data

Data from 1,671 patients with disabling migraine in the intent-to-treat (ITT) population of the double-blind, U.S. Phase III SAMURAI trial showed that single doses of 100 and 200 mg oral lasmiditan each met the secondary endpoint of a greater proportion of patients who achieved migraine headache pain relief at 2 hours post-dose vs. placebo (59.4% and 59.5%, respectively, vs. 42.2%, p<0.001 for both). Migraine headache relief was defined as moderate or severe headache pain at baseline reduced to mild or no headache pain at 2 hours post-dose. Patients in the lasmiditan arms were allowed to receive a second dose of lasmiditan if they were not headache pain free at 2 hours post-dose, or if their headache pain reoccurred within 24 hours of initial dosing. Lasmiditan also met the secondary endpoint of a greater proportion of patients who were free of headache pain at 2 hours after a rescue dose in both the low- (29% vs. 12.9%, p<0.001) and high-dose arms (26.6% vs. 23.1%, p<0.012) vs. placebo. ...