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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
First and only FDA-approved orally dissolving sublingual film for mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"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 8:30 a.m. ET NEW HAVEN, Conn., April 06, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence (AI) approaches to identify and develop transformative medicines in neuroscience and immuno-oncology, today announced that the U.S. Food and Drug Administration (FDA) has approved IGALMI™ (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.1 IGALMI can be self-administrated by patients under the supervision of a healthcare provider.1 The Company is prepared to launch IGALMI in the U.S. in the second quarter of 2022. “There are large numbers of patients who experience agitation associated with schizophrenia and bipolar disorders, and this condition has been a long-standing challenge for healthcare professionals to treat,” said Dr. John Krystal, M.D., the Robert L. McNeil, Jr. Professor of Translational Research and Chair of the Department of Psychiatry at Yale School of Medicine. “The approval of IGALMI, a self-administered film with a desirable onset of action, represents a milestone moment. It provides healthcare teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option.” An estimated 7.3 million people in the U.S. are diagnosed with schizophrenia or bipolar disorders.2-3 Up to a quarter of these people experience agitation, with episodes that can occur 10 to 17 times annually, totaling up to 25 million agitation episodes for these two patient populations per year.2-4 Agitation episodes are associated with a significant burden for patients, caregivers, and the healthcare system.5 “IGALMI is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade and represents a differe...