A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients With Military-Related PTSD
Phase of Trial: Phase III
Latest Information Update: 12 Jun 2017
At a glance
- Drugs Cyclobenzaprine (Primary)
- Indications Post-traumatic stress disorders
- Focus Registrational; Therapeutic Use
- Acronyms HONOR
- Sponsors Tonix Pharmaceuticals Holding Corp
- 12 Jun 2017 According to a Tonix Pharmaceuticals Holding Corp media release, this study will be presented at the 2017 Marcum MicroCap Conference.
- 11 Apr 2017 According to a Tonix Pharmaceuticals Holding Corp media release, the study will have one unblinded interim analysis (IA) by an independent data monitoring committee when the study has results from approximately 50% of efficacy-evaluable participants, or approximately 275 participants, which is projected to occur in the first half of 2018. If the IA results require continued enrollment, topline results from the 550-participants trial are expected to be available in the second half of 2018.
- 11 Apr 2017 According to a Tonix Pharmaceuticals Holding Corp media release, following the Initial Cross-Disciplinary Breakthrough Meeting in March, the FDA confirmed a single-study NDA approval could be possible based on statistically persuasive topline data from the ongoing HONOR study. Additionally, due to the lack of evidence of potential abuse in clinical studies of TNX-102 SL, the FDA agreed that studies in assessing abuse potential of TNX-102 SL are not required to support the TNX-102 SL NDA.