The FDA has approved dexmedetomidine sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
Today, the United States 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 the adult.1 Dexmedetomidine can be self-administered by patients under the supervision of a healthcare professional.
“There are a large number of patients who suffer from agitation associated with schizophrenia and bipolar disorder, and this condition has been a longstanding challenge for healthcare professionals to treat,” said John Krystal, MD, Robert L. McNeil, Jr. Professor of Translational Research and Chairman 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 landmark moment. It offers healthcare teams an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option.”
The approval of dexmedetomidine is based on data from 2 pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel-group trials: SERENITY I and SERENITY II. These trials evaluated dexmedetomidine for the acute treatment of agitation associated with schizophrenia (SERENITY I) and bipolar disorder I or II (SERENITY II).
The primary endpoint was the mean change from baseline in the total score of the excited component of the Positive and Negative Syndromes (PEC) scale. The change was assessed 2 hours after administration. The secondary endpoint was to find the earliest time when efficacy, measured by change from baseline in PEC score, was statistically separated from placebo.
Dexmedetomidine reached the primary endpoint in both trials 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 a statistically significant separation from placebo observed at 20 minutes for the 180 mcg and 120 mcg doses in SERENITY II and at 20 minutes and 30 minutes in SERENITY I.
“IGALMI is the first new acute treatment for schizophrenia or agitation associated with bipolar disorder in nearly a decade and represents a differentiated approach to helping patients manage this challenging and debilitating symptom,” said Vimal Mehta, PhD. , CEO of BioXcel Therapeutics.
BioXcel is ready to launch dexmedetomidine in the United States in the second quarter of 2022.
1. BioXcel Therapeutics announces FDA approval of IGALMI™ (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. BioXcel. Press release. April 6, 2022. https://ir.bioxceltherapeutics.com/news-releases/news-release-details/bioxcel-therapeutics-announces-fda-approval-igalmitm