Dexmedetomidine for Bipolar Disorder-Associated Acute Agitation Phase III Positive Results Published

On February 22, BioXcel announced that the results of a pivotal Phase III clinical trial of BXCL501 (sublingual dexmedetomidine) for the treatment of acute agitation symptoms associated with bipolar disorder were published in the Journal of the American Medical Association (JAMA)

BXCL501 is an investigational, proprietary oral-dissolving film formulation whose active ingredient is dexmedetomidine, a selective α2 receptor agonist, for the treatment of agitation symptoms associated with neuropsychiatric disorders

Agitated symptoms were significantly reduced in the BXCL501 120 mcg and 180 mcg groups compared with placebo after 2 hours of treatment, as measured by the change from baseline in the positive and negative psychiatric symptom rating scale-agitation state (PEC) total score

Specifically, for the primary endpoint, after 2 hours of treatment, the mean PEC total score change from baseline was -10.

On the prespecified exploratory endpoint, 90.

In terms of safety, the incidence of adverse events (AEs) for sublingual dexmedetomidine 180 mcg and 120 mcg was 35.

BioXcel has previously submitted a marketing application to the FDA based on the results of this study, with a PDUFA date of April 5, 2022

At present, the most widely used clinically is dexmedetomidine injection, which is used for sedation during tracheal intubation and mechanical ventilation