BioXcel Therapeutics announced that its 200-patient SERENITY At-Home pivotal Phase 3 safety trial has reached 33% enrollment. This trial is designed to evaluate the safety of BXCL501, an orally dissolving film formulation of dexmedetomidine, for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting.
The company expects topline data results from this trial in the second half of 2025. These results are intended to support a potential supplemental new drug application (sNDA) submission to expand the label of the FDA-approved IGALMI to include at-home use.
The SERENITY At-Home trial targets an estimated 23 million annual episodes of agitation in the U.S. at-home setting, where no FDA-approved therapies currently exist. The timely progress of enrollment is a positive indicator for the trial's advancement.
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