BioXcel Therapeutics announces first patient dosed in TRANQUILITY III study

BioXcel Therapeutics announced that the first patient has been dosed in the pivotal Phase 3 TRANQUILITY III trial of BXCL501 sublingual film, the Company’s proprietary, orally dissolving film, under investigation for the acute treatment of agitation in patients with Alzheimer’s disease, AD. The TRANQUILITY program includes two investigational studies, TRANQUILITY II and TRANQUILITY III, which are designed to evaluate the safety and efficacy of BXCL501 for the acute treatment of Alzheimer’s-associated agitation in adults 65 years and older in assisted living or residential care facilities and nursing homes. "The prevalence of Alzheimer’s disease is unfortunately increasing and there remains no FDA-approved product indicated for patients experiencing agitation associated with this condition," said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics. "With two pivotal trials underway in our TRANQUILITY program, we are aiming to expand BXCL501’s potential to treat the full spectrum of episodic and intermittent chronic agitation market, and address the costly health-care burden related to Alzheimer’s agitation."