Posted by Michael Wonder on 27 Dec 2018
BioXcel Therapeutics receives FDA fast track designation for BXCL501 for acute treatment of agitation
27 December 2018 - Fast track designation for BXCL501 will help facilitate anticipated registration trials in 2019 upon completion of pharmacokinetic (bioavailability) and safety study.
BioXcel Therapeutics today announced that the U.S. FDA has granted fast track designation for its investigational drug BXCL501, a proprietary sublingual film of dexmedetomidine, for the treatment of acute agitation.
BioXcel Therapeutics is currently conducting a Phase 1 study placebo-controlled, single dose, dose-escalation study of BXCL501. The study is expected to enro up to 60 healthy adult volunteers across various dosing groups. The primary endpoints are pharmacokinetics and safety, with secondary endpoints including assessment of pharmacodynamics and the relationship between BXCL501 concentrations and PD endpoints.
