Tonix Gets FDA Clearance To Develop Drug For Post-Traumatic Stress Disorder

(RTTNews) - Tonix Pharmaceuticals Holding Corp. (TNXP) Tuesday said that the FDA has cleared Investigational New Drug application to develop TNX-102 SL, a proprietary sublingual formulation of cyclobenzaprine HCl, for the treatment of post-traumatic stress disorder.

Post-traumatic stress disorder is a serious mental illness triggered by a traumatic event and is believed to affect more than eight million U.S. adults. Under this IND, Tonix will be able to move forward in the third quarter of this year with its planned U.S.-based Phase 2 clinical trial designed to evaluate the safety and efficacy of TNX-102 SL in patients with PTSD.

The planned randomized, double-blind, placebo-controlled Phase 2 clinical trial will investigate the safety and efficacy of two doses of TNX-102 SL and placebo administered once daily at bedtime.