FDA Okays First Sublingual Med for Agitation in Serious Mental Illness

The US Food and Drug Administration (FDA) has approved dexmedetomidine (Igalmi, BioXcel Therapeutics) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

This is the first FDA-approved, orally dissolving, self-administered sublingual treatment for this indication. With a demonstrated onset of action as early as 20 minutes, it shows a high response rate in patients at both 120 μg and 180 μg doses.

An estimated 7.3 million individuals in the US are diagnosed with schizophrenia or bipolar disorders, and up to one quarter of them experience episodes of agitation that can occur 10 to 17 times annually. These episodes represent a significant burden for patients, caregivers, and the healthcare system.

"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 healthcare 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 healthcare teams with an innovative tool to help control agitation. As clinicians, we welcome this much-needed new oral treatment option," he added.

"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.

The FDA approval of Igalmi is based on data from two pivotal randomized, double-blinded, placebo-controlled, parallel group phase 3 trials that evaluated Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) were somnolence, paresthesia or oral hypoesthesia, dizziness, dry mouth, hypotension, and orthostatic hypotension. All adverse drug reactions were mild to moderate in severity. While Igalmi was not associated with any treatment-related serious adverse effects in phase 3 studies, it may cause notable side effects, including hypotension, orthostatic hypotension, bradycardia, QT interval prolongation, and somnolence.

As previously reported by Medscape Medical News, data from the phase 3 SERENITY II trial that evaluated Igalmi in bipolar disorders were published on February 22 in the Journal of the American Medical Association.

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Cite this: Lolita Osorio. FDA Okays First Sublingual Med for Agitation in Serious Mental Illness - Medscape - Apr 08, 2022.