Tonix Pharmaceuticals, a clinical-stage biopharmaceutical company, announced the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the initiation of a phase 2 proof-of-concept study using TNX-102 SL for treatment of alcohol use disorder (AUD). The programme in AUD is expected to qualify for the 505(b)(2) pathyway for FDA approval.
“We are excited to have received the FDA's IND clearance to begin clinical trials for TNX-102 SL in AUD,” said Seth Lederman, M.D., chief executive officer of Tonix. “An estimated 36 million adults in the United States have AUD, a chronic relapsing brain disease characterized by compulsive alcohol use, loss of control over alcohol intake, and, very commonly, sleep disturbances which significantly impact cognition, mood and the ability to recover. We believe that by improving sleep quality, the mechanism of action of TNX-102 SL, the rate of successful recovery for people with AUD after detox can be improved.”