New Migraine Drug Cleared for Clinical Trials

CoLucid Pharmaceuticals, Inc. announced yesterday that it had received clearance from the FDA to proceed with clinical trials of lasmiditan, an oral drug to treat acute migraine. If approved, it would be a member of the first new class of migraine drugs to be made available in almost two decades.

Lasmiditan is designed to relieve migraines without the vasoconstrictor activity of currently available migraine drugs. It is part of a novel chemical class called ditans and works by penetrating the central nervous system and selectively targeting 5-HT1F receptors expressed in the trigeminal nerve pathway.

According to the company, five clinical studies of lasmiditan have been completed outside the US, including a Phase 2b study in which the drug achieved its primary endpoint of reducing moderate to severe headache to mild or none two hours after dosing. The company claims that in these trials lasmiditan has shown no evidence of cardiovascular side effects, unlike triptans and ergotamines currently used to treat migraines.

Source

CoLucid Pharmaceuticals Receives Clearance for Investigational New Drug (IND) Application for Lasmiditan for the Treatment of Acute Migraine [Press Release]