BioXcel Therapeutics Seeks FDA Approval for At-Home Agitation Treatment

BioXcel Therapeutics has received FDA acceptance for its supplemental New Drug Application (sNDA) for IGALMI®, seeking approval for at-home use in treating agitation associated with bipolar disorder. The Prescription Drug User Fee Act (PDUFA) target action date is November 14, 2026. If approved, IGALMI® could become the first FDA-authorized treatment option for acute agitation in the home setting, offering a significant advancement for patients and caregivers. This development represents a crucial step towards expanding access to effective agitation management solutions outside of clinical facilities.