BTAI News & Events

BioXcel Therapeutics announced positive topline results from a Phase 2 investigator-sponsored trial evaluating BXCL501 for the treatment of opioid withdrawal symptoms in adults with opioid use disorder undergoing a methadone taper. The study suggested that BXCL501 may be as effective as or superior to lofexidine 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 effects than lofexidine. Specifically, the most common CV adverse event for Lucemyra, orthostatic hypotension, was significantly lower for the 180 microgram twice daily BXCL501 dose group and remained lower in the highest 240 microgram BID BXCL501 dose group over the seven-day dosing period. There were no reports of sedation or somnolence in the BXCL501 treatment arms. These results support potential future development of BXCL501 in opioid withdrawal.

BioXcel Therapeutics announced the completion of an updated market opportunity assessment for Igalmi for acute agitation associated with bipolar disorders or schizophrenia in the at-home setting, informed by results from the SERENITY At-Home clinical study. The assessment represents a key milestone in the Company's commercial preparation initiatives for Igalmi, with findings intended to inform launch planning activities. A comprehensive launch plan for Igalmi in the at-home setting is in development. The Company submitted a supplemental New Drug Application last month seeking the FDA's approval of Igalmi for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. "This assessment further validates Igalmi's commercial opportunity in the at-home setting," said Mark Pavao, Interim Chief Commercial Officer of BioXcel Therapeutics. "The strong prescriber and patient interest, as well as positive payer feedback on potential formulary coverage, reinforce our confidence in launch planning and represent a critical step as we advance our commercial strategy. We will build on these insights as we develop and finalize a comprehensive launch plan."