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Phase 3 registrational study of TNX-102 SL for fibromyalgia-type Long COVID

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Trial Profile

Phase 3 registrational study of TNX-102 SL for fibromyalgia-type Long COVID

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2024

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At a glance

  • Drugs Cyclobenzaprine (Primary)
  • Indications Post acute COVID 19 syndrome
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 30 Sep 2024 According to a Tonix Pharmaceuticals Holding Corp media release, company expects to submit the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in October
  • 06 Sep 2023 New trial record
  • 05 Sep 2023 According to a Tonix Pharmaceuticals Holding Corp media release, the company intends to request an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss a potential Phase 3 program based on a proposed primary outcome measure using the PROMIS Fatigue scale and meeting is expected to take place in the first quarter of 2024.

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