BioXcel announced that its IND application for the firm’s sublingual film formulation of dexmedetomidine has received clearance from the FDA.
BioXcel Therapeutics (NASDAQ:BTAI) announced that its investigational new drug (IND) application for the firm’s proprietary sublingual thin-film formulation of dexmedetomidine has received clearance from the US Food and Drug Administration (FDA) for the treatment of opioid withdrawal symptoms.
As quoted in the press release:
“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.”