Migraine Treatment Gets Cleared for NDA

CoLucid Pharmaceuticals, Inc announced that it has received clearance to proceed with clinical studies of lasmiditan under IND 103,420 from the FDA, marking the first new treatment to be introduced for acute migraines in nearly 2 decades.

Lasmiditan (formerly known as COL-144) is an oral tablet formulation of a Neurally Acting Anti-Migraine Agent designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapies. Lasmiditan is a member of a novel chemical class called ditans, and unlike triptans, which target vasoconstrictor 5-HT1B receptors, lasmiditan penetrates the central nervous system and selectively targets 5-HT1F receptors expressed in the trigeminal nerve pathway.

Five clinical studies have been successfully completed outside of the United States, including a Phase 2b double blind placebo controlled dose ranging study treating a single migraine attack which was completed in 2010. In the study, 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. Differentiation of individual doses from placebo was seen as early as 30 minutes after dosing.

Lasmiditan also achieved numerous secondary endpoints per other migraine symptoms such as nausea, photophobia and phonophobia. Importantly, the drug’s side effect profile is highly differentiated from triptans and ergotamines, and there was no evidence of drug-related cardiovascular effects or chest symptoms in the previous five clinical studies, according to CoLucid Pharmaceuticals.

"The migraine market, estimated at 30 million sufferers in the US, is an under-served market. No new class of therapies has been introduced for the treatment of acute migraine since the triptan class, which was first launched almost 20 years ago," said CoLucid CEO Thomas P. Mathers in a statement. "Patient and physician feedback note that only a portion of migraine patients are adequately controlled on triptans, and patients would welcome a new product that could offer a rapid speed of onset, superior pain relief and/or a lack of cardiovascular side effects as compared to currently available products.”

He also noted that due to their vasoconstrictor activity, triptans are contraindicated in patients with cardiovascular disease. This is critical, as many physicians feel uncomfortable prescribing triptans due to their potential cardiovascular side effects.

“Lasmiditan may address these unmet needs with its novel mechanism of action, and we look forward to the results of the Phase 3 trials to confirm its rapid speed of onset, superior pain relief and lack of cardiovascular side effects," said Mathers.