Business
BioXcel Therapeutics Announces Update on NIDA-funded Trial of BXCL501 (sublingual dexmedetomidine) for Potential Treatment of Opioid Use Disorder (OUD)
Columbia University-led trial expected to add fourth site to target completion of 4-arm, 160-patient trial in 2024 Fentanyl adulterated or associated with
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Columbia University-led trial expected to add fourth site to target completion of 4-arm, 160-patient trial in 2024 Fentanyl adulterated or associated with xylazine (FAAX) designated an emerging threat by the White House Office of National Drug Control Policy1 Company to seek FDA feedback on potential registrational paths NEW HAVEN, Conn., Nov. 06, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced an update on the National Institute on Drug Abuse (NIDA)-funded trial evaluating BXCL501 (sublingual dexmedetomidine) as a potential treatment for opioid use disorder (OUD). BioXcel Therapeutics is supplying BXCL501 for an ongoing 4-arm, 160-patient trial that is enrolling patients who have been predominantly exposed to fentanyl and/or predominantly exposed to fentanyl adulterated or associated with xylazine (FAAX), which has been designated an emerging threat by the White House Office of National Drug Control Policy1. NIDA has requested Columbia University, the trial coordinator, to add a fourth site to target trial completion in 2024. After this time, BioXcel Therapeutics plans to seek FDA feedback on potential registrational paths.* According to NIDA, xylazine has been linked to an increasing number of overdose deaths nationwide in the evolving drug addiction and overdose crisis. Studies show people exposed to xylazine often knowingly or unknowingly used it in combination with other drugs, particularly illicit fentanyl.2 Recently, the Biden administration requested $46 billion in its fiscal 2024 National Drug Control Budget3 to address the opioid epidemic, while opioid settlements reached between U.S. state and local governments and the 14 major pharmaceutical opioid manufacturers, distributors, and retailers have aggregated between $51 billion and nearly $55 billion.4 “We have long known that the locus coeruleus drives various opioid withdrawal symptoms5 but have lacked access to a sublingual formulation of dexmedetomidine, one of the most potent and selective alpha 2-adrenergic receptor agonists available, as a treatment option,” said Dr. Sandra Comer, Principal Investigator of the trial and Professor of Neurobiology in the Department of Psychiatry at Columbia University. “With BXCL501...