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The safety and efficacy of Methylene Blue MMX modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Trial Profile

The safety and efficacy of Methylene Blue MMX modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Mar 2019

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At a glance

  • Drugs Methylthioninium chloride-Cosmo (Primary)
  • Indications Adenoma; Colorectal cancer
  • Focus Diagnostic use; Registrational
  • Sponsors Cosmo Pharmaceuticals; Cosmo Technologies
  • Most Recent Events

    • 12 Mar 2019 FDA Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER) denied Cosmo's last appeal while reiterating the need of a phase III confirmatory trial for approval of the drug.Company has no intention to peruse any additional appeal with the FDA. The company intends to conduct a phase III confirmatory trial and will present a new clinical protocol to the FDA with different endpoints.
    • 05 Jun 2018 Results presented at the Digestive Disease Week 2018
    • 23 May 2018 According to a Cosmo Pharmaceuticals media release, the CRL states that the FDA has determined that it cannot approve the NDA in its present form. The CRL states that although the outcome from this trial has translated in a statistically significant outcome, the outcome is not sufficiently robust and thus recommends to provide confirmation of effectiveness with a second phase III trial.
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