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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: 06 Mar 2025

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At a glance

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

    • Most Recent Events

    • 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.
    • 17 Dec 2024 According to a Tonix Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia. The FDA is expected to assign the NDA a Prescription Drug User Fee Act (PDUFA) target action date in a Day 74 Letter.

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