BioXcel Therapeutics announced enrollment of the first patients in a U.S. Department of War-funded Phase 2a clinical trial evaluating BXCL501 (sublingual dexmedetomidine) for the treatment of acute stress reactions. The double-blind, placebo-controlled trial is being led by the University of North Carolina at Chapel Hill Institute of Trauma Recovery and is designed to enroll 100 patients experiencing acute stress reactions following motor vehicle collisions. The trial will evaluate the potential of BXCL501 to reduce acute stress reaction symptom severity, improve neurocognitive function, and prevent progression to chronic posttraumatic neuropsychiatric symptoms.
Acute stress reaction symptoms occur in the days and weeks after trauma and include anxiety, sleep disturbance, concentration difficulty, pain, and somatic symptoms such as dizziness and lightheadedness. Chronic adverse posttraumatic neuropsychiatric symptoms occur when acute stress reactions do not resolve and include persistent pain, posttraumatic stress, and depressive symptoms. Acute stress reactions affect more than 40 million Americans who seek emergency department care annually after traumatic stress exposure. The reactions are common among service members, police and other first responders, and survivors of shootings and natural disasters.
The 2023 VA/Department of War Clinical Practice Guidelines for management of posttraumatic stress disorder and acute stress reactions recommend trauma-focused psychotherapy, specifically cognitive-behavioral therapy, as the primary treatment to reduce acute stress reaction symptoms and prevent posttraumatic stress disorder. Pharmacotherapy is generally not recommended for treating acute stress reactions, and benzodiazepines are contraindicated. A positive outcome from this trial could contribute to a reassessment of those guidelines and establish a pharmacological treatment pathway for patients suffering from acute stress reactions.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://menafn.com/1110956920/Bioxcel-Therapeutics-Announces-Enrollment-Of-First-Patients-In-US-Department-Of-War-Funded-Study-Of-BXCL501-Sublingual-Dexmedetomidine-For-Treatment-Of-Acute-Stress-Reactions