BioXcel Therapeutics expands indication for med to treat withdrawal symptoms

BioXcel  Therapeutics announced proof-of-concept data from its Phase 1b study of intravenously-administered dexmedetomidine in patients suffering from opioid withdrawal symptoms. The positive data from this Phase 1b trial provides evidence to expand the potential market for BXCL501, a proprietary sublingual film of Dex, beyond its current focus for acute treatment of agitation in neuropsychiatric indications. The study further confirms that BXCL501’s selective alpha-2a adrenergic receptor mechanism has potential application in opioid withdrawal symptoms, in addition to the acute treatment of agitation in schizophrenia, bipolar disorder and dementia. Opioid addiction is difficult to overcome largely because of the severe symptoms associated with withdrawal, an area in need of more effective non-opioid treatment options. BTI conducted the clinical study in a total of 15 patients with opioid dependence. Ten subjects were enrolled in the treatment arm while five subjects were enrolled in the placebo arm. Symptoms of opioid withdrawal were evaluated using the Clinical Opioid Withdrawal Scale, or COWS, an 11-item scale that measures a constellation of withdrawal symptoms experienced after abstaining from opioid use. All ten subjects receiving IV Dex responded to treatment, while there were no responders in the placebo arm. Results from this study demonstrated that IV Dex effectively mitigated the physiological symptoms of opioid withdrawal. These encouraging results support further expansion of BXCL501 for the treatment of withdrawal symptoms associated with opioid abuse. Additionally, previously published studies support the potential of Dex as an adjunctive treatment for symptoms of alcohol withdrawal.
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