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A Pivotal Phase 3 randomised, double blind, placebo-controlled phase III study of Wafermine (Ketamine sublingual) in patients undergoing abdominoplasty

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Trial Profile

A Pivotal Phase 3 randomised, double blind, placebo-controlled phase III study of Wafermine (Ketamine sublingual) in patients undergoing abdominoplasty

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 21 Nov 2020

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At a glance

  • Drugs Ketamine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors iX Biopharma

Most Recent Events

  • 10 Nov 2020 According to an iX Biopharma media release, with the successful outcome of the EMA Scientific Advice and End-of-Phase 2 meeting with the US FDA, the company has now reached consensus with the regulators of the major markets of Europe and the United States on the remaining clinical development required to support the approval of Wafermine for the treatment of acute moderate to severe pain in those markets.
  • 10 Nov 2020 According to an iX Biopharma media release, the company announced that it has received positive feedback from the European Medicines Agency (EMA) in its scientific advice to the company regarding its Phase 3 clinical development programme for Wafermine, its sublingual ketamine wafer, for registration in Europe. In the EMA Scientific Advice, the EMA endorsed the company's proposed design of the pivotal Phase 3 studies.
  • 18 Dec 2019 New trial record

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