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A Prospective, Double-blind, Randomized, Placebo and Active Controlled, Multi-center, Parallel Group Study Comparing Remimazolam to Placebo, With an Additional Open-label Arm For Midazolam, in Patients Undergoing a Colonoscopy

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Trial Profile

A Prospective, Double-blind, Randomized, Placebo and Active Controlled, Multi-center, Parallel Group Study Comparing Remimazolam to Placebo, With an Additional Open-label Arm For Midazolam, in Patients Undergoing a Colonoscopy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jul 2021

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At a glance

  • Drugs Remimazolam (Primary) ; Midazolam
  • Indications Sedation
  • Focus Registrational; Therapeutic Use
  • Sponsors PAION

    • Most Recent Events

    • 29 Jun 2021 According to a PAION media release, the company announced that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo (remimazolam besylate) in adults for procedural sedation. Based on data from comprehensive U.S. Phase III clinical program in procedural sedation in patients undergoing bronchoscopy or colonoscopy.
    • 12 Jan 2021 According to a PAION media release, company expects that the CHMP (Committee for Medicinal Products for Human Use) will publish its recommendation on the MAA by the end of January 2021. The European Commission will review the CHMP recommendation and a final decision is expected in the first half of 2021.
    • 12 Aug 2020 According to a PAION media release, a decision on Marketing Authorization Application (MAA) approval for procedural sedation to the European Medicines Agency (EMA) is currently expected in the beginning of 2021 at the earliest
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