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Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients

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Trial Profile

Randomised, Double-blind, Placebo-controlled Phase III Study of APD421 (Amisulpride for IV Injection) as Combination Prophylaxis Against Post-operative Nausea and Vomiting in High-risk Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Apr 2024

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At a glance

  • Drugs Amisulpride (Primary) ; Antiemetics
  • Indications Postoperative nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Sponsors Acacia Pharma

    • Most Recent Events

    • 15 Apr 2024 According to an Eagle Pharmaceuticals media release, results data assessing the sustained response of amisulpride for the rescue treatment of postoperative nausea and vomiting will be presented at the upcoming American Society of PeriAnesthesia Nurses (ASPAN) 2024 National Conference, which is being held April 14-18, 2024, in Orlando, Florida.
    • 29 Sep 2021 According to a Acacia Pharma media release, based data from four positive Phase 3 studies, the company has submitted a Marketing Authorization Application (MAA) for BARHEMSYS (amisulpride injection) to prevent and treat postoperative nausea & vomiting (PONV). The MAA has been validated and is now under formal review in major European markets. The review process is expected to be completed by Q3/2022.
    • 27 Feb 2020 According to an Acacia Pharma media release, the US Food and Drug Administration (FDA) has approved BARHEMSYS (amisulpride injection) for the prevention and treatment of PONV in adult patients.
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