Oral Dissolving Film Rapidly Eases Acute Agitation in Patients with Schizophrenia

An oral dissolving film for sublingual or buccal administration of dexmedetomidine was effective and well-tolerated for the rapid treatment of acute agitation in patients with schizophrenia, according to a poster presented at the virtual 2021 American Psychiatric Association Annual Meeting.

“BXCL501 is an orally dissolving film formulation of the a_2A-adrenergic receptor agonist dexmedetomidine,” wrote lead author Leslie Citrome, MD, MPH, of the psychiatry department at New York Medical College, Valhalla, New York, and coauthors. “This formulation bypasses first-pass metabolism to rapidly achieve high bioavailability of dexmedetomidine."

The double-blind, phase 3 trial randomized 380 adults with acute agitation 1:1:1 to BXCL501 120 µg, 180 µg, or a matching placebo film. To be eligible, patients had to have a total score of ≥14 on the five items of the PANSS-Excited Component (PEC) scale, with a score ≥4 on at least one of the items.

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Among 372 patients who completed the study, the median age was 45.6 years, 63% were men, the average baseline PEC total score was 17.6. All patients self-administered the films.

From baseline to 120 minutes after administration, the average decrease in PEC total score was 4.8 for patients who received placebo, 8.5 for those who received BXCL501 120 µg, and 10.3 for patients who received BXCL501 180 µg, results showed. Significant improvement in PEC total score was observed as early as 20 minutes with BXCL501 180 µg, and 30 minutes with BXCL501 120 µg. Improvements were maintained at 4, 6, and 8 hours after administration.

No severe or serious adverse events were reported, according to the study. The most common adverse event was somnolence, which was reported by 22% of participants who received BXCL501. About two-thirds of patients who received BXCL501 liked the taste. More than 90% said the study medication had no unpleasant aftertaste.

“BXCL501 possesses a novel mechanism of action and differentiating route of administration that makes it potentially favored over currently existing therapeutic option for treating agitation,” researchers concluded.

BioXcel Therapeutics, the developer of BXCL501, funded the study.

—Jolynn Tumolo

Reference

Citrome L, Lauriello J, Risinger R, Krystal J. A novel rapidly effective treatment of agitation for schizophrenia with the oral dissolving film BXCL501. Poster presented at the American Psychiatric Association Annual Meeting; May 1-3, 2021; Virtual.