Massachusetts General Hospital will use a New Haven biotechnology company’s experimental agitation drug to treat symptoms of “ICU delirium” in critically ill patients hospitalized with COVID-19.
BioXcel Therapeutics said Thursday that doctors at the hospital will have access to the company’s drug, BXCL501, for “compassionate use” under the U.S. Food & Drug Administration’s expanded access program.
The program allows patients with an immediately life-threatening condition to receive experimental drugs before regulatory approval and outside of clinical trials in cases where there are no comparable or satisfactory therapies available.
Medical professionals have been reporting a high number of critically ill COVID-19 patients on ventilators experiencing ICU delirium — a sudden, intense confusion that can include hallucinations.
Dr. Seun Johnson-Akeju, anesthetist in chief at Mass. General’s department of anesthesia, critical care and pain medicine, said the hospital’s intensive care workers have witnessed the increase firsthand.
“The COVID-19 surge caused an acute shortage of medications for managing agitation,” Johnson-Akeju added. “We are hopeful that BXCL501 will improve the clinical outcomes of critically ill patients diagnosed with COVID-19 that are struggling with agitation and ICU delirium.”
BXCL501 is a thin-film version of an older Pfizer drug, dexmedetomidine (Dex). It looks similar to a mouthwash strip and dissolves under the tongue.
BioXcel is currently testing the drug in four separate clinical trials to treat agitation associated with dementia, bipolar disorder, schizophrenia and opioid withdrawal.
