The US Food and Drug Administration (FDA) has allowed CoLucid Pharmaceuticals to start clinical trials of lasmiditan (formerly known as COL-144) under IND 103,420 to treat acute migraine.
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The results from Phase 2b study suggested that lasmiditan achieved its primary endpoint of reducing a moderate or severe headache at baseline to mild or none 2 hours after dosing in 391 patients.
In total, the company has released positive data from around five clinical trial evaluating lasmiditan.
Currently, CoLucid is speaking with potential partners, interacting with the FDA and intends to advance lasmiditan into Phase 3 development.
CoLucid CEO Thomas Mathers said lasmiditan may address these unmet needs with its novel mechanism of action, and they look forward to the results of the Phase 3 trials to confirm its speed of onset, superior pain relief and lack of cardiovascular side effects.
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