15 March 2021 - Designation offers the potential for expedited development and review, highlighting the urgent need for new treatment options for dementia related agitation.
BioXcel Therapeutics today announced that BXCL501, the Company's investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine has been granted breakthrough therapy designation from the U.S. FDA for the acute treatment of agitation associated with dementia.