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"
Latest Information Update: 22 Sep 2024
At a glance
- Drugs Cyclobenzaprine (Primary)
- Indications Post-traumatic stress disorders
- Focus Proof of concept; Therapeutic Use
- Acronyms AtEase
- Sponsors Tonix Pharmaceuticals Inc
- 21 Aug 2024 According to a Tonix Pharmaceuticals media release, data from this study and the HONOR study, evaluating TNX-102 in the Aftermath of Trauma to Reduce Acute Stress Disorder (ASD) and Prevent Military-Related PTSD , will be presented in a poster presentation on August 27, 2024, 3:00 p.m. - 5:00 p.m. ET, at the 2024 Military Health System Research Symposium (MHSRS), being held August 26-29, 2024, in Kissimmee, Fla.
- 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- 22 Apr 2019 According to a Tonix Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has withdrawn its previously issued Breakthrough Therapy Designation Rescind letter and confirmed that the Breakthrough Therapy designation granted in December 2016 remains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).