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 Viewpoint - The FDA has concluded the inspection of a site involved in BioXcel Therapeutics' TRANQUILITY II trial, indicating that the data from this trial is reliable and supports the company's potential sNDA submission for BXCL501 [1][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] BXCL501 Overview - BXCL501 is an investigational sublingual film formulation of dexmedetomidine, currently approved as IGALMI by the FDA [3] - It is being investigated for the acute treatment of agitation associated with Alzheimer's dementia and bipolar disorders or schizophrenia in at-home settings [3] - BXCL501 has received Breakthrough Therapy designation for agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [3] TRANQUILITY In-Care Phase 3 Trial - 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 with varying degrees of dementia [4] - The primary endpoint is a change in the Positive and Negative Syndrome Scale-Excitatory Component total score at two hours post-first dose [4]