Business
BioXcel Therapeutics Announces Compassionate Use Program at Massachusetts General Hospital for BXCL501 to Treat COVID-19 Patients Suffering from Delirium and Agitation
Company providing BXCL501 to evaluate its activity in patients with COVID-19 that may require calming or arousable sedation following intubation NEW HAVEN,
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Company providing BXCL501 to evaluate its activity in patients with COVID-19 that may require calming or arousable sedation following intubation\nNEW HAVEN, Conn., July 09, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced that the Company has initiated an expanded access program at Massachusetts General Hospital (“MGH”) to provide its investigational drug, BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine (“Dex”), to critically ill patients diagnosed with COVID-19 in the intensive care unit (\"ICU\") that may require calming or arousable sedation.\n “We are pleased to support clinicians at MGH as they manage an in-flux of COVID-19 patients,” commented Vimal Mehta, Ph.D., Chief Executive Officer of BTI. “COVID-19 primarily affects the respiratory system, with the severely ill often requiring mechanical ventilation. As a result of critical illness and the medical coma that is necessary for mechanical ventilation, patients frequently develop delirium and agitation, causing worse clinical outcomes and extended hospital stays. BXCL501 is being studied in advanced clinical trials to treat acute agitation, and we believe it has the potential, if approved, to help physicians treat patients that may be struggling with agitation or delirium.” Facilitated by the U.S. Food and Drug Administration (“FDA”), expanded access, also known as compassionate use, provides an opportunity for patients to receive an investigational treatment prior to regulatory approval when there are no comparable or satisfactory therapeutic alternatives available. “Being on the frontlines of this pandemic, our intensivists have witnessed firsthand the high numbers of critically ill patients diagnosed with COVID-19 and ICU delirium,” added Seun Johnson-Akeju, M.D., M.M.Sc., Anesthetist-in-Chief of the Department of Anesthesia, Critical Care and Pain Medicine at the Massachusetts General Hospital. “The COVID-19 surge caused an acute shortage of medications for managing agitation. We are hopeful that BXCL501 will improve the clinical outcomes of critically ill patients diagnosed with COVID-19 that are struggling...