FDA approves sublingual treatment for agitation

BioXcel Therapeutics has announced the FDA approval of Igalmi, a sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Igalmi (dexmedetomidine), which can be self-administered by patients under the supervision of a health care provider, is the first and only FDA-approved orally dissolving sublingual film for this indication, the company said in a press release. It will be available in the U.S. in the second quarter of 2022.

The FDA approval is based on data from two randomized, double-blind, placebo-controlled, parallel group phase 3 trials, according to the release. SERENITY I evaluated the treatment in people with schizophrenia, and SERENITY II looked at those with bipolar I or II disorder.

The studies showed an onset of action as early as 20 minutes and a high response rate with two doses: 120 mcg and 180 mcg, BioXcel said.

“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,” John Krystal, MD, the Robert L. McNeil Jr. Professor of Translational Research and chair of the department of psychiatry at Yale School of Medicine, said in the release. “[This] 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.”

BioXcel Therapeutics CEO Vimal Mehta, PhD, said in the release, “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.”