BioXcel Completes Phase 3 At-Home IGALMI Agitation Trial

BioXcel Therapeutics said it has completed the last patient last visit in its pivotal SERENITY At-Home Phase 3 safety trial of IGALMI, a 120-microgram sublingual film of dexmedetomidine (BXCL501) for the acute treatment of agitation linked to bipolar disorders or schizophrenia in an outpatient setting. The double-blind, placebo-controlled study enrolled more than 200 adults across 22 U.S. sites and captured data from over 2,200 agitation episodes during a 12-week period. Completion of the trial keeps the company on track to release top-line results later this month. BioXcel plans to use the data to file a supplemental New Drug Application aimed at expanding IGALMI’s current hospital-only label to at-home use. If approved, the drug would become the first FDA-cleared therapy for an estimated 23 million annual agitation episodes that occur outside healthcare facilities in the United States. Investors welcomed the milestone: BioXcel shares rose about 30 % in pre-market trading on 1 August.