BioXcel Phase 3 Targets 23M Annual Episodes: 1st At-Home Treatment for Bipolar, Schizophrenia Agitation

BioXcel Therapeutics (Nasdaq: BTAI) has completed the last patient visit in its pivotal Phase 3 SERENITY At-Home clinical trial, evaluating IGALMI® (dexmedetomidine) for treating agitation in bipolar disorders or schizophrenia patients at home. The study collected data from over 2,200 agitation episodes across more than 200 patients at 22 sites nationwide.

The double-blind, placebo-controlled trial tested a 120 mcg dose of BXCL501 and aims to support a supplemental New Drug Application (sNDA) to expand IGALMI's label for outpatient use. Topline data is expected this month. If approved, IGALMI would become the first FDA-approved therapy for the estimated 23 million annual episodes of bipolar or schizophrenia-related agitation occurring at home in the U.S.

https://www.stocktitan.net/news/BTAI/bio-xcel-therapeutics-announces-last-patient-last-visit-in-serenity-axhfyhi465bd.html