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| BXCL501 demonstrated clinical benefits and favorable tolerability profile for treatment of opioid withdrawal symptoms |
| Results from this NIDA-funded study support potential future development of BXCL501 in opioid withdrawal |
| Opioid use disorder is a global health crisis, affecting approximately 5.9 million adults in the U.S. |
NEW HAVEN, Conn., March 05, 2026 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company built on artificial intelligence (“AI”) to develop transformative medicines in neuroscience, today announced positive topline results from a Phase 2 investigator-sponsored trial (IST) evaluating BXCL501 for the treatment of opioid withdrawal symptoms in adults with opioid use disorder (OUD) undergoing a methadone taper.
The study suggested that BXCL501 may be as effective as or superior to lofexidine (Lucemyra®) for reducing the symptoms of opioid withdrawal during methadone taper, while having a more convenient dosing regimen and demonstrating a favorable tolerability profile. In this study, BXCL501 had similar or lower overall rates of cardiovascular (CV) effects than lofexidine. Specifically, the most common CV adverse event for Lucemyra, orthostatic hypotension, was significantly lower for the 180 µg twice daily (BID) BXCL501 dose group (18% vs 50% lofexidine, p
