15 Aug Lasmiditan Passes Phase II Study
Another entry in the race to develop a new generation of migraine treatments is showing promise. Lasmiditan (also known as COL-144) was found to be effective for acute migraine attacks in a Phase IIb study. CoLucid Pharmaceuticals, Inc. describes the drug as “a first-in-class Neurally Acting Anti-Migraine Agent (NAAMA) designed to deliver efficacy in migraine without the vasoconstrictor activity associated with previous generations of migraine therapy. COL-144 selectively targets 5HT1F receptors expressed in the trigeminal nerve pathway.”
In the double-blind, randomized, placebo-controlled study, which was conducted in five European countries, 391 patients took one of four oral doses of lasmiditan or placebo to treat a single migraine attack. According to CoLucid, there was a “highly significant correlation” between lasmiditan and headache relief after two hours. Certain dose levels showed significant benefit compared to placebo as early as 30 minutes after treatment. Study subjects also reported relief from other migraine symptoms, including nausea and light and sound sensitivity. The most common adverse events were dizziness and fatigue. Cardiovascular problems occurred at the same frequency as with the placebo.
“Currently available drugs have varying efficacy and side effects that limit their use in patients,” said James F. White, PhD, President and Chief Executive Officer of CoLucid, in a press release. “Lasmiditan, with its exciting new mechanism of action, has the potential to address these patient needs.”
Phase III studies are scheduled to begin this fall.