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A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)

Trial Profile

A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 26 Nov 2019

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At a glance

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

    • 26 Nov 2019 According to a Tonix Pharmaceuticals media release, the company announced that it has received the official minutes from the Breakthrough Therapy Type B Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA) for Tonmya (or TNX-102 SL, cyclobenzaprine sublingual tablets) for the treatment of posttraumatic stress disorder (PTSD). The minutes are consistent with the the guidance received at the meeting.
    • 04 Nov 2019 According to a Tonix Pharmaceuticals media release, results from added Interim analysis are expected in the first quarter of 2020 and top-line data are expected in the second quarter of 2020. 125 participants have been enrolled in this trial till date.
    • 04 Nov 2019 According to a Tonix Pharmaceuticals media release, the company has revised the trial protocol based on guidance from its recent Breakthrough Therapy Type B Clinical Guidance meeting with the U.S. Food and Drug Administration (FDA).
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