A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken at Bedtime in Subjects With Military-Related PTSD and Related Conditions (Protocol No. TNX-CY-P201) -"AtEase STUDY"
Phase of Trial: Phase II
Latest Information Update: 22 Apr 2019
At a glance
- Drugs Cyclobenzaprine (Primary)
- Indications Post-traumatic stress disorders
- Focus Therapeutic Use
- Acronyms AtEase
- Sponsors Tonix Pharmaceuticals Inc
- 22 Apr 2019 According to a Tonix Pharmaceuticals media release, the FDA has reversed itself and granted the Company a meeting in June to present additional data to support continuing Breakthrough Therapy designation.
- 22 Apr 2019 According to a Tonix Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has withdrawn its previously issued Breakthrough Therapy Designation Rescind letter and confirmed that the Breakthrough Therapy designation granted in December 2016 remains in effect for Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of posttraumatic stress disorder (PTSD).
- 01 Mar 2019 According to a Tonix Pharmaceuticals media release, the U.S. FDA notified the company that the Breakthrough Therapy designation (BTD) granted for Tonmya for PTSD in December 2016 has been rescinded because interim analysis data on Tonmya from the HONOR study do not support the continuation of the BTD (as of 1st Mar 2019).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History