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# FDA OK’s Igalmi for Schizophrenia/Bipolar Agitation
- URL: https://www.fdaweb.com/fda-oks-igalmi-for-schizophrenia-bipolar-agitation/
- Published: 2022-04-06T12:00:00.000Z
- Updated: 2026-09-14T17:39:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151538

FDA has approved a BioXcel Therapeutics NDA for Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or Bipolar I or II disorder in adults. This is the first new acute treatment for schizophrenia or bipolar disorder-associated agitation in nearly a decade and “represents a differentiated approach to helping patients manage this difficult and debilitating symptom,” BioXcel says. The drug, which *demonstrated onset of action as early as 20 minutes,* can be self-administrated by patients under the supervision of a healthcare provider, it adds.

BioXcel says that about 7.3 million people in the U.S. are diagnosed with schizophrenia or bipolar disorders, and up to 25% of these people experience agitation, with episodes that can occur 10 to 17 times annually.

Approval was based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel group Phase 3 trials. In both trials, Igalmi met the primary endpoint at two hours of demonstrating statistically significant improvements from baseline. It also met the key secondary endpoint — demonstrating a rapid onset of action, with “statistically significant separation from placebo observed at 20 minutes for both the 180 mcg and 120 mcg doses in SERENITY II and 20 minutes and 30 minutes in SERENITY I, respectively,” the company says.