FDA Approves Novel Therapy for Schizophrenia and Bipolar

The FDA has approved Igalmi (dexmedetomidine) for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. Developed by BioXcel Therapeutics, Igalmi is a sublingual film formulation of dexmedetomidine, a selective alpha-2 receptor agonist.

It is available in two doses: 120 mcg and 180 mcg. BioXcel expects to launch the therapy in the second quarter of 2022.

John Krystal, M.D.

“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, M.D., the Robert L. McNeil, Jr. Professor of Translational Research and Chair of the Department of Psychiatry at Yale School of Medicine.

An estimated 7.3 million people in the United States are diagnosed with schizophrenia or bipolar disorders. Up to a quarter of these patients experience agitation, with episodes that can occur 10 to 17 times annually.

The approval is based on data from two phase 3 trials evaluating Igalmi for the acute treatment of agitation associated with schizophrenia (SERENITY I) or bipolar I or II disorder (SERENITY II).

In both trials, Igalmi met the primary endpoint, which was Positive and Negative Syndrome Scale-Excited Component (PEC) total score at two hours. This is an investigator-rated score for measuring agitation in patients that evaluates poor impulse control, tension, hostility, uncooperativeness, and excitement.

Igalmi also met the key secondary endpoint, demonstrating a rapid onset of action, with statistically significant separation from placebo observed at 20 minutes. The most common adverse reactions were drowsiness, dizziness, dry mouth, and low blood pressure.

The company expects to submit a marketing application in Europe for this same indication in the first half of 2022.

BioXcel also is conducting a phase 3 trial of Igalmi for agitation in Alzheimer’s disease, and has submitted an investigational new drug application to evaluate the therapy as an adjunct treatment for major depressive disorder.