BioXcel Therapeutics (BTAI) Announces FDA Approval of IGALMI Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults

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Go back to BioXcel Therapeutics (BTAI) Announces FDA Approval of IGALMI Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults

BioXcel Therapeutics Announces FDA Approval of IGALMI™ (dexmedetomidine) Sublingual Film for Acute Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder in Adults

April 6, 2022 7:00 AM EDT

First and only FDA-approved orally dissolving sublingual film for mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder1

IGALMI demonstrated onset of action as early as 20 minutes and high response rate with both 120 mcg and 180 mcg doses in pivotal studies1

Up to 25 million agitation episodes for these two patient populations in the U.S. annually2-3

U.S. commercial launch planned for Q2 2022

Company to host investor conference call on April 6, 2022 at... More