BioXcel Therapeutics (BTAI)  announces the initiation of a Phase 2 PLACIDITY trial of BXCL501, the company’s investigational orally dissolving thin film formulation of dexmedetomidine ((Dex)), for the treatment of delirium related agitation.The PLACIDITY trial is a multicenter, randomized, double-blind, placebo-controlled, ascending dose-finding study designed to evaluate the safety, efficacy, and pharmacokinetics of BXCL501 in intensive care unit adult patients experiencing delirium related agitation, including COVID-19 patients. About 20 patients will be randomized into each sequential ascending dose cohort (starting doses of 120 ug, 180 ug, 240 ug, or 300 ug), or matching placebos to determine an optimal starting dose that could effectively and safely reduce agitation.The primary endpoint is the reduction in agitation measured by at least a 2-point drop in the Richmond Agitation Sedation Scale at two hours post BXCL501 administration.Delirium is a serious condition that occurs in a variety of hospital settings, including frequently in the intensive care unit, and

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BioXcel starts mid-stage BXCL501 trial for treatment of delirium related agitation