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A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in Patients Undergoing Bronchoscopy

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Trial Profile

A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in Patients Undergoing Bronchoscopy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2021

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At a glance

  • Drugs Remimazolam (Primary) ; Fentanyl; 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 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
  • 02 Jul 2020 According to an Acacia Pharma media release, the US Food and Drug Administration (FDA) has approved BYFAVO (remimazolam) for injection for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.

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