BioXcel Therapeutics Announces Last Patient Last Visit in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

Core Insights - BioXcel Therapeutics has completed the last patient last visit (LPLV) in the pivotal Phase 3 SERENITY At-Home clinical trial, with topline data expected to be released this month to support a supplemental New Drug Application (sNDA) for IGALMI in the at-home setting [1][3] Group 1: Clinical Trial Details - The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study evaluating the safety of a 120 mcg dose of BXCL501 for treating agitation associated with bipolar disorders or schizophrenia in an at-home setting [2][4] - The trial enrolled over 200 patients across 22 sites nationwide, ensuring no single site enrolled more than 11% of the total patient population, with a balanced distribution between bipolar disorders and schizophrenia [2][4] Group 2: Market Opportunity - There are approximately 23 million episodes of agitation related to bipolar disorders or schizophrenia annually in the U.S. that occur at home, with no FDA-approved therapies currently available for acute treatment in this setting [3][4] - The company aims to provide a much-needed at-home treatment option for individuals experiencing such agitation, marking a significant milestone in its development efforts [3] Group 3: Product Information - BXCL501, known as IGALMI, is an investigational orally dissolving film formulation of dexmedetomidine, currently approved for use under healthcare supervision for acute treatment of agitation associated with schizophrenia and bipolar disorder [5][6] - The product has received Breakthrough Therapy designation from the FDA for treating agitation associated with dementia and Fast Track designation for agitation related to schizophrenia and bipolar disorders [5]