BioXcel Therapeutics, Inc. (BTAI) on Thursday reported positive topline results from a Phase 2 study evaluating BXCL501 for the treatment of opioid withdrawal symptoms in adults with opioid use disorder undergoing a methadone taper. Shares rose more than 12% in pre-market trading following the announcement.
The study indicated that BXCL501 may be as effective as or superior to Lucemyra, an FDA-approved non-opioid medicine, in reducing opioid withdrawal symptoms, while offering a more convenient dosing schedule and a favorable tolerability profile.
BXCL501 demonstrated similar or lower overall rates of cardiovascular side effects compared with lofexidine, and no cases of sedation or somnolence were reported in the BXCL501 groups, compared with 5% in the Lucemyra arm.
The findings build on earlier results from the Phase 1b/2 RELEASE study, which established the tolerability of selected BXCL501 doses in opioid-dependent patients. They also complement positive Phase 3 results for BXCL501 in treating acute agitation associated with bipolar disorder, schizophrenia and Alzheimer's disease.
BioXcel stock closed at $1.65 on Wednesday, up 3.13%.
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