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BioXcel Therapeutics Announces FDA Clearance of IND Application for BXCL501 for the Treatment of Opioid Withdrawal Symptoms
Company is preparing to initiate Phase 1b/2 RELEASE trial NEW HAVEN, Conn., Feb. 05, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”)
About this update from Bioxcel Therapeutics, Inc.
[{"type":"text","content":"Company is preparing to initiate Phase 1b/2 RELEASE trial\nNEW HAVEN, Conn., Feb. 05, 2020 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (“BTI” or “Company”) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to identify and advance the next wave of medicines in neuroscience and immuno-oncology, today announced that its Investigational New Drug (“IND”) application for BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine (“Dex”), has received clearance from the U.S. Food and Drug Administration (“FDA”) for the treatment of opioid withdrawal symptoms.\n “The FDA clearance of our IND application for opioid withdrawal, a fourth indication, is an important step in our plans to build a neuroscience franchise around the multiple therapeutic opportunities with BXCL501,” commented Vimal Mehta, Chief Executive Officer of BTI. “Opioid overdose is reported as the number one cause of death for those under 50 years old in the U.S., and the distressing and challenging symptoms that come with opioid withdrawal are a primary reason for relapse. There is an urgent need for better treatment options to help manage the debilitating withdrawal symptoms and aid this underserved population from continued opioid abuse. BXCL501, our investigational non-opioid therapy, may offer key advantages to treating symptoms due to its intrinsic potency and favorable delivery method. We believe this study will build on the encouraging results we observed in our intravenous (“IV”) Dex trial, which appeared effective in reducing opioid withdrawal symptoms.” Opioid withdrawal is an emotional and physiological medical condition that may be driven by the excessive drive of noradrenergic neurons that originate from the locus coeruleus in the brainstem. BXCL501 selectively activates alpha-2a adrenergic receptors, which decreases excessive neuronal firing, alleviating the physiological symptoms of opioid withdrawal. The RELEASE trial is a multicenter, randomized, double-blind, placebo-controlled, ascending-dose Phase 1b/2 study designed to evaluate the safety, pharmacokinetics, tolerability and efficacy of BXCL501 in patients experiencing symptoms of opioid withdrawal. This study will enroll subjects with opioid use disorder who are physically dependent on opioids. Patients will be rando...