Feb. 05, 2020: BioXcel Therapeutics announced that its IND application for BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine, has received clearance from the U.S.FDA for the treatment of opioid withdrawal symptoms.
“Opioid overdose is reported as the number one cause of death in the United States for those under the age of 50 years, and the distressing and challenging symptoms of opioid withdrawal are a primary reason for relapse.
Better treatment options are urgently needed to help manage the debilitating withdrawal symptoms and help this underserved population from continued opioid abuse. BXCL501, our investigational non-opioid therapy, may present key advantages to treating symptoms due to its intrinsic effectiveness and favorable delivery method.
Opioid withdrawal is an emotional and physiological medical condition which may be caused by the intense drive of the noradrenergic neurons that arise in the brainstem from the locus coeruleus.
The RELEASE trial is a Phase 1b/2 multicenter, randomized, double-blind, placebo-controlled, ascending dose study designed to determine the health, pharmacokinetics, tolerability and effectiveness of BXCL501 in patients with opioid withdrawal symptoms.
Patients are administered twice daily for five days to be randomized into several dose cohorts of BXCL501, or equivalent placebo.
BXCL501 is a potential first-in-class, proprietary sublingual thin film made of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of acute agitation.
Also,BXCL501 has also been granted Fast Track Designation by the U.S. FDA for the acute treatment of agitation.