The FDA has designated a BioXcel drug a “breakthrough therapy” for dementia-related agitation, a label that has the potential to speed up the regulatory review process.
BioXcel said the FDA based its decision on positive topline data from a recent Phase 1b/2 clinical trial showing statistically significant reductions in agitation in patients two hours after taking the drug.
CEO Vimal Mehta said it “further underscores the significant unmet need for a new treatment for this underserved patient population.”