FDA Approves First Orally Dissolving Sublingual Film For Schizophrenia-Associated Agitation
April 6, 2022   


The U.S. Food and Drug Administration (FDA) has approved dexmedetomidine (IGALMI, BioXcel Therapeutics), an orally dissolving sublingual film for mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder. Dexmedetomidine is a selective α-2A-adrenergic receptor agonist. The orally dissolving film (ODF) is designed to rapidly dissolve and be absorbed sublingually or buccally, bypassing first-pass liver metabolism. The FDA approval is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel group Phase 3 trials evaluating IGALMI for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II). In both trials, dexmedetomidine met the primary endpoint at two hours after the first dose in patients treated with the 120 µg,g and 180 µg,g doses, demonstrating statistically significant improvements from baseline.

The phase 3 SERENITY II trial included almost 380 adults with bipolar I or II disorder and acute agitation. The primary efficacy end point was the mean change from baseline at 2 hours for the Positive and Negative Syndrome Scale-Excited Component (PEC). Two hours after taking the medication, the mean changes from baseline in PEC total score were -10.4 for sublingual dexmedetomidine 180 µg, -9.0 for sublingual dexmedetomidine 120 µg, and -4.9 for placebo. Treatment effects began 20 minutes after taking the medication among patients in the sublingual dexmedetomidine groups. Mild to moderate adverse events (AEs) occurred in 35.7% of patients taking 180 µg of dexmedetomidine, 34.9% taking 120 µg, and 17.5% taking placebo. The most common AEs (=5%) were somnolence, dry mouth, hypotension, and dizziness. No drug-related severe or serious AEs occurred.

This sublingual dexmedetomidine formulation is a non-invasive treatment that avoids the need for injections and can be self-administered by the patient under the supervision of a healthcare provider. This novel mechanism of action and differentiating route of administration may make it potentially favored over current existing therapeutic options for treating agitation.

>> BioXcel Therapeutics Press Release


Preskorn SH et al. JAMA. 2022;327(8):727. Abstract

For more information:

      Austin, TX or Virtual   |   Session Highlight
Anger Aside: Dealing With Agitation in People with Schizophrenia or Bipolar Disorder
Presented by: Leslie L. Citrome, MD, MPH
Session Overview: Agitation can present in the context of many psychiatric disorders, including schizophrenia and bipolar disorder. This presentation discusses strategies for managing agitation and preventing escalation to violence and aggression.
    >>   Register for In Person or Online Simulcast


Encore Presentation
Bipolar Disorder: A Spectrum Disorder with a Spectrum of Treatments
CME/CE Credit: 1.0 | Expires: November 8, 2023


Encore Presentation
Short Circuits? Exploring the Neurobiology Behind Violence and Aggression
CME/CE credits: 1.0 | Expires: November 3, 2024


Encore Presentation
Psychiatric Emergency: Assessment and Management of Agitation
CME/CE credits: 1.0 | Expires: November 10, 2022


NEI Podcast
Episode 95 - (CME) What’s Real? Practical Management of Dementia-Related Psychosis
CME/CE Credit: 0.75 | Expires: December 14, 2023


Encore Presentation
Agitation and Psychosis in Dementia: Practical Management
CME/CE credits: 0.75 | Expires: November 8, 2023