New Approval for Treatment of Agitation Associated with Schizophrenia or Bipolar I or II Disorder

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Today, the US Food and Drug Administration (FDA) approved BioXcel Therapeutics dexmedetomidine (Igalmi™) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.¹ Dexmedetomidine can be self-administrated by patients under the supervision of a health care provider.

“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 health care professionals to treat,” said John Krystal, MD, 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 health care teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option.”

Dexmedetomidine’s approval is based on data from 2 pivotal randomized, double-blinded, placebo-controlled, parallel group phase 3 trials: SERENITY I and SERENITY II. These trials evaluated dexmedetomidine for the acute treatment of agitation associated with schizophrenia (SERENITY I), and bipolar I or II disorder (SERENITY II).

The primary endpoint was mean change from baseline in the Positive and Negative Syndrome Scale-Excited Component (PEC) total score. Change was assessed 2 hours following dosing. The secondary endpoint was to find the earliest time where efficacy, measured by the change from baseline in PEC score, was statistically separated from placebo.

Dexmedetomidine met the primary endpoint in both trials at 2 hours after the first dose in patients treated with the 120 mcg and 180 mcg doses, demonstrating statistically significant improvements from baseline. IGALMI also met the key secondary endpoint, 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.

“IGALMI 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,” said Vimal Mehta, PhD, CEO of BioXcel Therapeutics.

BioXcel is prepared to launch dexmedetomidine in the US in the second quarter of 2022.

Reference

1. 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. BioXcel. News release. April 6, 2022. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-fda-approval-igalmitm