BioXcel Therapeutics announces update on NIDA-funded trial of BXCL501

BioXcel Therapeutics announced an update on the National Institute on Drug Abuse, NIDA,-funded trial evaluating BXCL501 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, which has been designated an emerging threat by the White House Office of National Drug Control Policy. 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. “While BXCL501 has already demonstrated statistical significance in patients exposed to fentanyl, this current study has a high proportion of patients exposed to FAAX and is comparing 180 mcg and 240 mcg BID doses to both placebo and the standard of care, lofexidine,” said Robert Risinger, M.D., Chief Medical Officer, Neuroscience of BioXcel Therapeutics. “BXCL501 is one of the only potential treatments being studied in this patient population and represents an important potential option to help address the growing OUD crisis.”