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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 Fibromyalgia

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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 Fibromyalgia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Apr 2025

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At a glance

  • Drugs Cyclobenzaprine (Primary)
  • Indications Fibromyalgia
  • Focus Registrational; Therapeutic Use
  • Acronyms RELIEF
  • Sponsors Tonix Pharmaceuticals Inc

    • Most Recent Events

    • 07 Apr 2025 According to a Tonix Pharmaceuticals media release, company presented data from this study and RESILIENT study, in a poster presentation session at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting, held April 3-6, 2025, in Austin, Texas.
    • 04 Mar 2025 According to a Tonix Pharmaceuticals media release, company presented data in an oral presentation at the 7th International Congress on Controversies in Fibromyalgia, held March 3-4, 2025, in Vienna, Austria.
    • 23 Dec 2024 According to a Tonix Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on marketing approval for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia.

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