BioXcel reports positive Phase 3 safety and efficacy results for BXCL501 agitation in home setting

BioXcel Therapeutics, Inc.

BXCL501 (sublingual dexmedetomidine) safe and well-tolerated in 12-week home-use study (SERENITY At-Home).
No increase in adverse events with repeat dosing; 81% of treated patients completed the study.
Exploratory efficacy: greater reduction in mCGI-S vs placebo (P<0.05); complete resolution higher with BXCL501 (P<.0001).
No patient on active arm discontinued due to TEAE; results support potential label expansion for unsupervised use.

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