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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

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Trial Profile

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

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2024

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At a glance

  • Drugs Cyclobenzaprine (Primary)
  • Indications Post-traumatic stress disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms HONOR
  • Sponsors Tonix Pharmaceuticals Holding Corp

    • Most Recent Events

    • 08 Mar 2024 According to a Tonix Pharmaceuticals media release,the company announced Publication in Psychiatry Research Showing Activity of Bedtime TNX-102 SL on PTSD Symptoms and Sleep Quality in Military-Related PTSD at Four Weeks of Therapy
    • 12 Nov 2020 According to a Tonix Pharmaceuticals media release, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, outlined a new statistical method to analyze future Posttraumatic Stress Disorder (PTSD) drug studies and presented a retrospective analysis using the new method of the Phase 3 HONOR study (P301) of TNX-102 SL , for the treatment of military-related PTSD at the 3rd Annual Neuropsychiatric Drug Development Summit today.
    • 01 Mar 2019 According to a Tonix Pharmaceuticals media release, the U.S. FDA notified the company that the BTD granted for Tonmya for PTSD in December 2016 has been rescinded because interim analysis data on Tonmya from the HONOR study do not support the continuation of the BTD.The BTD granted to Tonmya was based on retrospective analysis of the effect of Tonmya 5.6 mg in the Phase 2 AtEase study in military-related PTSD, that shows a substantial improvement over existing therapies in military-related PTSD.
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