BioXcel wins FDA clearance re opioid withdrawal drug

BioXcel Therapeutics reports that its Investigational New Drug application for BXCL501, the Company’s proprietary sublingual thin-film formulation of dexmedetomidine, has received clearance from the FDA for the treatment of opioid withdrawal symptoms.

“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,” said Vimal Mehta, Chief Executive Officer of BioXcel. more