Processing Your Payment

Please do not leave this page until complete. This can take a few moments.

February 26, 2021

BioXcel launches trial for delirium-related agitation drug

PHOTO | STEVE LASCHEVER BioXcel Therapeutics CEO Vimal Mehta
By Natalie Missakian

New Haven’s BioXcel Therapeutics on Thursday announced the start of Phase 2 human testing to see if its anti-agitation drug can calm patients with delirium.

This would be the fifth potential disease indication BioXcel is eyeing for BXCL501, which is similar to a mouthwash strip. 

The drug is a thin-film version of an older drug, dexmedetomidine, or Dex, which was sold by Pfizer under the brand name Precedex and was previously used in the operating room as an anesthetic. 

BioXcel found the drug using artificial intelligence and repurposed it to treat agitation, creating a new formulation that tastes minty and dissolves in the mouth.

The trial, which it calls PLACIDITY, will enroll around 20 patients who will randomly receive ascending doses of the drug or a placebo, BioXcel said. Its goal is to determine an optimal starting dose that could safely and effectively reduce agitation. The trial will be looking for a two-point drop in agitation as measured by a commonly used sedation scale.

The company expects to receive initial results in early 2022.

CEO Vimal Mehta said in a statement that the drug, if approved, would be a welcome therapy option for the roughly 4 million U.S. patients who suffer from delirium-related agitation annually. The condition frequently occurs in the intensive care unit, with patients sometimes attempting to remove catheters and IV lines.

“Treating agitation associated with delirium remains a challenge for healthcare workers and patients, as there are no FDA-approved therapies and off-label treatments are sub-optimal, resulting  in serious medical complications and extended hospital stays,” Mehta said. 

BioXcel has already applied for Food and Drug Administration approval of the drug for patients with schizophrenia and bipolar disorder. A decision could come for those indications before the end of the year, BioXcel has said. 

It is also testing the drug for agitation related to dementia and opioid withdrawal.

Contact Natalie Missakian at news@newhavenbiz.com

Sign up for Enews

Most Recent

Most Recent

0 Comments

Order a PDF