Tonix Receives FDA Clearance For PTSD Drug IND
Clinical-stage pharmaceutical company Tonix Pharmaceuticals announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to develop TNX-102 SL for the treatment of post-traumatic stress disorder (PTSD).
TNX-102 SL is a proprietary sublingual formulation of cyclobenzaprine HCl designed to ease pain from fibromyalgia and improve quality of sleep in those with PTSD.
Seth Lederman, Chairman and CEO of Tonix, said, “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 approval of the IND allows Tonix to advance into a double-blind, randomized, placebo-controlled Phase 2 clinical trial program to investigate the safety and efficacy of TNX-102 SL in patients with PTSD. The 12-week study is expected to enroll around 220 patients with military-related PTSD across 30 sites in the U.S. The primary endpoint will be comparison of differences in mean scores on the Clinician-Administered PTSD Scale (CAPS).
Post-traumatic stress disorder is a serious mental illness thought to affect over 8 million adults in the U.S. The condition is common among first-responders veterans and other military-related personnel. The condition is triggered and can be developed from seeing or undergoing traumatic events. PTSD is associated with suicide and impulsive violent behavior, and often has limited treatment options
“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,” Lederman said.
The company said it expects to begin the Phase 2 trial of TNX-102 SL in PTSD in the third quarter of the year.