BioXcel’s Schizophrenia and Bipolar-Associated Agitation Drug Approved

BioXcel Therapeutics has gained the FDA’s approval for Igalmi, its sublingual film formulation of dexmedetomidine, for the treatment of agitation associated with schizophrenia or bipolar disorder.

The drug is a sedative that is commonly administered by continuous infusion during surgical procedures.

The approval was based on data from two phase 3 trials in which participants given the sublingual treatment in 120-mg or 180-mg doses showed a significant decrease in agitation.

All adverse events in the two trials were mild to moderate, but the drug’s possible side effects include low blood pressure, a slowed heart rate and drowsiness.