Phase III data for lasmiditan demonstrates rapidity of action in migraine treatment- CoLucid Pharma
CoLucid Pharmaceuticals provided additional data regarding onset of action demonstrated as soon as 30 minutes after dosing for 100 mg and 200 mg of lasmiditan from its Phase III pivotal trial evaluating lasmiditan, the SAMURAI study in migraine. In addition, CoLucid presented non-clinical data supporting the mechanism of action of lasmiditan through central nervous system (CNS) penetration, distribution into areas of the brain relevant to migraine pathophysiology, expression of the 5-HTIF receptor mRNA in relevant regions of the brain, inhibition of trigeminal nociceptive responses, and lack of any vasoconstrictive activity in non-clinical models.
Data from the SAMURAI study were collected using electronic diaries during the treated attack. Beginning pre-dose, patients indicated their degree of headache pain on a 4-point scale: 0, no pain; 1, mild pain; 2, moderate pain; or 3, severe pain. Migraine headache relief was defined as moderate or severe headache pain at baseline reduced to mild or no headache pain at the time point assessment. Lasmiditan was effective at both the 100 mg dose and the 200 mg dose in relieving migraine headache pain as soon as 30 minutes as compared to placebo. Data were presented at the 5th European Headache and Migraine Trust International Congress (EHMTIC) in Glasgow, Scotland, U.K.
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