The First in its Class
Lasmiditan, (COL-144), has been designed to deliver efficacy in migraine without the vasoconstrictor effects of other migraine therapies. It is a member of a novel chemical class called "ditans" which penetrates the central nervous system (CNS) and selectively targets 5-HT1F receptors expressed in the trigeminal nerve pathway.
The FDA has cleared lasmiditan to proceed with clinical studies in the US (August 2011). Five clinical studies, including a Phase 2b trial, have been successfully completed outside of the U.S. No evidence of drug-related cardiovascular effects or chest symptoms have been noted in the five clinical studies.
Key findings from the Phase 2b trial include:
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Primary Endpoint Met
Moderate or severe headache reduced to mild or none 2 hours after dosing (p<0.0001) -
30 Minutes after Dosing
Individual doses differentiated from placebo
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Secondary Endpoints Achieved
Nausea, photophobia, phonophobia -
Differentiated Side Effect Profile
As compared to triptans and ergotamines
Thus lasmiditan is a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), differentiated from the current leading acute migraine therapies. The International Nonproprietary Name (INN) Committee assigned a non-triptan generic stem name ("ditan") to lasmiditan based on its unique chemical structure, receptor selectivity, and mechanism of action.
