BioXcel Drug Calms Agitation At Home For Schizophrenia, Bipolar Patients

Core Insights - BioXcel Therapeutics, Inc. released topline exploratory efficacy data from the SERENITY At-Home Pivotal Phase 3 safety trial, showing that BXCL501 has continued effects and consistent benefits with repeat dosing [1] - The trial evaluated a 120 mcg dose of BXCL501 for agitation associated with bipolar disorders or schizophrenia, demonstrating significant efficacy compared to placebo [2] Efficacy Results - Across 2,433 treated episodes, BXCL501 showed a significant mean reduction in the modified Clinical Global Impression–Severity (mCGI-S) score from baseline compared to placebo at 2 hours [2] - Complete resolution of agitation symptoms was observed in 50% of patients in the BXCL501 arm compared to 33% in the placebo group [3] - Severe agitation episodes fully resolved in 61% of cases in the BXCL501 arm versus 18% on placebo, while moderate and mild episodes resolved in 43% and 60% of cases, respectively, compared to 34% and 40% on placebo [4] Dosage Impact - A mean reduction in mCGI-S score of 1.2 was noted after the first 12 doses, increasing to a mean reduction of 1.4 after 13 or more doses of BXCL501 [5] - Igalmi, the formulation of BXCL501, is currently FDA-approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings [5] Market Reaction - BioXcel Therapeutics shares increased by 3.07% to $3.69 at the time of publication, trading within a 52-week range of $1.17 to $13.36 [6]