BioXcel Therapeutics, Inc. (BTAI) Wednesday announced positive topline exploratory efficacy data from the SERENITY At-Home Phase 3 study of BXCL501, the company's proprietary, sublingual film formulation of dexmedetomidine, IGALMI, for treatment of agitation associated with bipolar disorders or schizophrenia.
BXCL501 showed a significant mean reduction in mCGI-S score from baseline compared to placebo at 2 hours across treated agitation episodes. Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across agitation episode severity. Additionally, BXCL501 showed a similar reduction in agitation symptoms over both the duration of the study and number of treated episodes, demonstrating continued effects and consistent benefit with repeat dosing of BXCL501.
BioXcel had previously reported positive topline safety results last month, and is reporting additional findings today.
The company plans to submit sNDA for expanded usage of IGALMI in the outpatient setting in the first quarter of 2026.
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