FDA Approves Dexmedetomidine for Agitation From Bipolar Disorders, Schizophrenia

BioXcel plans to launch Igalmi sublingual film in the United States in the second quarter of 2022.

The FDA has approved dexmedetomidine (Igalmi, BioXcel Therapeutics) sublingual film for the treatment of adults with agitation associated with bipolar disorders 1 and 2 and schizophrenia.

Dexmedetomidine can be self-administered under the supervision of a health care provider. BioXcel plans to launch the drug in the United States in the second quarter of 2022.

“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, chair of the Department of Psychiatry at Yale School of Medicine, said in a statement.

“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,” Krystal said.

The approval of the dexmedetomidine film is based on data from 2 double-blinded, phase 3, placebo-controlled, randomized trials evaluating the use of the drug for the acute treatment of agitation associated with schizophrenia, analyzed in the SERENITY I trial, or bipolar 1 or 2 disorder, analyzed in the SERENITY II trial.

The primary endpoint of the trials was the mean change from baseline in the Positive and Negative Syndrome Scale-Excited Component (PEC) total score assessed at 2 hours following dosing. PEC is an investigative rated tool for measuring agitation in individuals with elements associated with agitation, such as excitement, hostility, poor impulse control, tension, and uncooperativeness.

Both trials met the primary endpoint at 2 hours after the first dose with the 120 and 180 mcg doses. They both also met the key secondary endpoints at 20 minutes for both 180 and 120 mcg doses in SERENITY II and 20 minutes and 30 minutes in SERENITY I, respectively.

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

“With this landmark achievement of our first approved drug, we have taken a monumental step toward our mission of bringing transformative medicines in neuroscience to patients using our [artificial intelligence] platform. We believe IGALMI has significant market-changing potential, and we are excited to execute on our commercial launch plans in the U.S. this quarter,” Mehta said.

Although there were no serious AEs in the studies, it can cause bradycardia, dizziness, dry mouth, hypotension, oral hypoesthesia, orthostatic hypotension, paresthesia, QT interval prolongation, and somnolence.

The findings from the phase 3 SERENITY II trial were published in the Journal of the American Medical Association (JAMA) on February 22, 2022.


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. Globe Newswire. News release. April 6, 2022. Accessed April 6, 2022. Email.

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