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A Phase 3, Multicenter, Randomized, Double Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

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Trial Profile

A Phase 3, Multicenter, Randomized, Double Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo in the Management of Postoperative Pain Following Bunionectomy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2022

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At a glance

  • Drugs Tramadol (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Avenue Therapeutics

    • Most Recent Events

    • 22 Sep 2022 According to an Avenue Therapeutics media release, the Company intends to incorporate the FDA's suggestions from the meeting minutes and submit a detailed study protocol that could form the basis for the submission of a complete response to the second Complete Response Letter for IV Tramadol.
    • 22 Sep 2022 According to an Avenue Therapeutics media release, the company in type A meeting with FDA presented a study design for a single safety clinical trial that the Company believes could address the concerns regarding risks related to opioid stacking. The FDA stated that the proposed study design appears reasonable and agreed on various study design aspects with the expectation that additional feedback would be provided to Avenue upon review of a more detailed study protocol.
    • 15 Feb 2022 According to an Avenue Therapeutics media release, in the U.S. FDA joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol voted on applicant submission of adequate information to support product outweigh the risks for the management of acute pain severe enough to require an opioid analgesic in an inpatient setting. The results are 8 yes votes and 14 no votes.

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