BioXcel Therapeutics Announces FDA Closed its Inspection of Site for Phase 3 TRANQUILITY II Trial for Acute Treatment of Agitation Associated with Alzheimer's Dementia

Core Insights - The FDA has concluded the inspection of a site involved in the TRANQUILITY II Phase 3 trial of BXCL501, indicating "Voluntary Action Indicated," which supports the reliability of the trial data [1][2] - BioXcel Therapeutics is advancing its TRANQUILITY In-Care Phase 3 trial for BXCL501, having received FDA feedback on the trial protocol [2] Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company focused on developing transformative medicines in neuroscience using artificial intelligence [5] - The company has a subsidiary, OnkosXcel Therapeutics, which is dedicated to immuno-oncology [5] Product Information - BXCL501 is an investigational orally dissolving film formulation of dexmedetomidine, currently approved as IGALMI® for specific indications [3] - BXCL501 is being investigated for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders, with Breakthrough Therapy and Fast Track designations from the FDA [3] Trial Details - The TRANQUILITY In-Care trial is a double-blind, placebo-controlled study evaluating the efficacy and safety of a 60 mcg dose of BXCL501 over 12 weeks for agitation in Alzheimer's dementia patients [4] - The trial aims to enroll approximately 150 patients aged 55 and older residing in care facilities, with the primary endpoint being a change in the Positive and Negative Syndrome Scale-Excitatory Component total score [4]