Under the IND application, the company will be able to move forward in the third quarter of 2014 with its planned US-based Phase II clinical trial designed to assess the safety and efficacy of TNX-102 SL in patients with PTSD, a serious mental illness triggered by a traumatic event.
Tonix chairman and chief executive officer Seth Lederman said the clearance of this IND represents an important milestone for the company and for the estimated eight million US adults with PTSD, a serious illness with unmet needs and limited treatment options.
"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," Lederman said.
"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 II clinical trial (TNX-CY-P201) will evaluate the safety and efficacy of two doses of TNX-102 SL and placebo administered once daily at bedtime.
About 220 patients with military-related PTSD are expected to be enrolled in the 12-week trial to be carried out at about 30 sites in the US.
Primary efficacy analysis of the trial will compare differences in mean scores on the Clinician-Administered PTSD Scale (CAPS).