BioXcel Therapeutics, Inc. (BTAI) said on Tuesday that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for IGALMI, seeking approval for the acute treatment of agitation associated with bipolar disorder or schizophrenia in an outpatient setting.
IGALMI sublingual film was initially approved by the FDA in April 2022 for the acute treatment of agitation in adults with schizophrenia or bipolar I or II disorder under healthcare provider supervision. The sNDA aims to expand the label to allow treatment in an outpatient setting without such supervision. The submission was supported by data from the Phase 3 SERENITY At-Home safety trial.
BioXcel shares were down more than 4% in pre-market trading after closing at $1.84 on Friday, down 3.92%.
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