Us2.ai receives FDA clearance for Us2.v2,transforming…

September 19, 2012 

Durham-based CoLucid Pharmaceuticals, Inc. has reached an agreement with the U.S. Food and Drug Administration’s Division of Neurology Products on the strategy the young pharma will follow in developing its migraine drug candidate.

The drug, lasmiditan, is intended for patients with, or at risk of, cardiovascular disease, as well as patients who haven’t gotten help from some other treatments. Six clinical studies have been successfully completed so far, including a Phase 2b double blind placebo study where the drug achieved its primary endpoint.

Durham-based Pappas Ventures launched the company in 2005. So far, CoLucid has raised about $50 million in multiple rounds, including more than $7 million last year to fund Phase 3 trials of lasmiditan.