BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting

Core Viewpoint - BioXcel Therapeutics has submitted a supplemental New Drug Application (sNDA) to the FDA for IGALMI, aiming to expand its use for the acute treatment of agitation associated with bipolar disorders or schizophrenia in outpatient settings, with potential approval by the end of 2026 [1][3]. Company Overview - BioXcel Therapeutics, Inc. is a biopharmaceutical company utilizing artificial intelligence to develop innovative medicines in neuroscience [11]. - The company focuses on drug re-innovation, leveraging existing approved drugs and machine learning to identify new therapeutic indications [11]. Product Information - IGALMI (dexmedetomidine) is the first orally dissolving sublingual film approved for treating agitation associated with schizophrenia and bipolar disorders under healthcare supervision [2][5]. - The sNDA submission seeks to allow treatment in outpatient settings without healthcare supervision, addressing a significant unmet medical need [2][3]. Clinical Trial Results - The sNDA is supported by the successful completion of the Phase 3 SERENITY At-Home safety trial, where IGALMI met its primary endpoint of being well-tolerated in the at-home setting [4]. - The safety profile of IGALMI in the trial was consistent with the approved label, indicating its potential for broader use [4]. Market Opportunity - There are approximately 7.3 million individuals in the U.S. diagnosed with schizophrenia or bipolar disorders, with an estimated 57 to 77 million annual agitation episodes occurring [3]. - The company is conducting a market opportunity assessment to evaluate commercialization strategies for IGALMI [3].