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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2022

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At a glance

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

Most Recent Events

  • 26 Oct 2022 Post hoc analysis (n=31) assessing changes in pertinent vital signs - heart rate (HR), respiratory rate (RR), systolic and diastolic blood pressure (SYSBP, DIABP), transcutaneous carbon dioxide partial pressure (TcCO2) and oxygen saturation (SaO2) - were analyzed as a function of MOAA/S score in patients sedated with remimazolam presented at the ANESTHESIOLOGY 2022 Annual Meeting of the American Society of Anesthesiologists
  • 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.
  • 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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