BioXcel Therapeutics (BTAI) announced completion of the last patient last visit, LPLV, in the Phase 3 SERENITY At-Home clinical trial. Topline data from the study are expected to be released this month and are intended to support the planned supplemental New Drug Application, sNDA, to potentially expand the label of IGALMI for use in the at-home setting. The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The SERENITY At-Home study enrolled more than 200 patients across 22 sites nationwide, with no single site enrolling more than 11% of the total patient population.
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