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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 RESILIENT
  • Sponsors Tonix Pharmaceuticals Inc

Most Recent Events

  • 07 Apr 2025 According to a Tonix Pharmaceuticals media release, company presented data from this study and the RELIEF 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.
  • 24 Mar 2025 According to a Tonix Pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) will not require an Advisory Committee meeting to discuss the Companys New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia.
  • 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.

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