NEW YORK, June 10, 2014 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP), a clinical-stage pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to develop TNX-102 SL, a proprietary sublingual formulation of cyclobenzaprine HCl, for the treatment of post-traumatic stress disorder (PTSD). PTSD 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 clearance of this IND represents an important milestone for Tonix and for the estimated eight million U.S. adults with PTSD, a serious illness with unmet needs and limited treatment options," stated Seth Lederman, M.D., Chairman and Chief Executive Officer of Tonix. "As with our IND of TNX-102 SL for fibromyalgia, our goal is to develop a new approach to a common central nervous system disorder with the potential to alter treatment paradigms. We are very excited about investigating the safety and efficacy of TNX-102 SL in PTSD while our potential pivotal study in fibromyalgia, the BESTFIT trial, has completed enrollment with top-line results available later this year."
The planned randomized, double-blind, placebo-controlled Phase 2 clinical trial (TNX-CY-P201) will investigate the safety and efficacy of two doses of TNX-102 SL and placebo administered once daily at bedtime. This 12-week study is expected to enroll approximately 220 patients with military-related PTSD at about 30 sites in the U.S. The primary efficacy analysis will compare differences in mean scores on the Clinician-Administered PTSD Scale (CAPS).About Post-Traumatic Stress Disorder PTSD is a type of anxiety disorder believed to affect approximately eight million people in the U.S., and is a common problem among veterans, first-responders and other military-related personnel. PTSD can develop from witnessing or experiencing traumatic events, and is linked to suicide and to impulsive violent behavior.