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BioXcel Therapeutics Announces NIH NIDA Grant to Columbia University to Support Further Studies of BXCL501 (Sublingual Dexmedetomidine) for Treating Opioid Withdrawal
Multi-year-funded award to support a 160-patient, randomized-controlled study in patients undergoing opioid withdrawal treatment Over 142 million opioid
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Multi-year-funded award to support a 160-patient, randomized-controlled study in patients undergoing opioid withdrawal treatment Over 142 million opioid prescriptions dispensed in the U.S. in 20201 More than 1.7 million people in the U.S. suffered from substance use disorders related to prescription opioid pain relievers in 20161 NEW HAVEN, Conn., Aug. 01, 2022 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a commercial-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that the National Institute on Drug Abuse, part of the National Institutes of Health (NIH), has awarded Columbia University a multi-year NIDA grant to fund clinical testing of BXCL501 (sublingual dexmedetomidine) as a potential treatment for opioid withdrawal. The initial grant provides approximately $3.3 million for the project from August 1, 2022 through July 31, 2024 to support a 4-arm Phase 2b study comparing BXCL501 180 mcg and 240 mcg BID to placebo and Lucemyra™, to be followed by approximately $4.5 million to support a registrational study upon the completion of certain milestones. Opioid abuse has long been recognized as a national health crisis. More than 142 million opioid prescriptions were dispensed in the U.S. in 2020, according to the Centers for Disease Control and Prevention (CDC), which also estimates that 1.7 million people in the U.S. suffered from substance use disorders related to prescription opioid pain relievers in 2016. In addition, the drug overdose epidemic claimed an estimated 104,000 lives in the 12-month period ending in September 20211 and a White House Council of Economic Advisers recently assessed the cost of the opioid crisis at $1 trillion2. Columbia University enrolled patients in the RELEASE trial — a multicenter, randomized, double-blind, placebo-controlled, ascending dose Phase 1b/2 trial designed to evaluate the safety, pharmacokinetics, tolerability, and efficacy of BXCL501 administered twice daily for seven days — in patients experiencing symptoms of opioid withdrawal. In March 2021, BioXcel Therapeutics announced RELEASE top line results. BXCL501 was generally well tolerated, with no severe or serious adverse events reported across all doses evaluated (30 mcg, 60 mcg, 90 mcg, 120 mcg, 180 mc...