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Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had Prior Prophylaxis

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Trial Profile

Randomised, Double-blind, Placebo-controlled Study of APD421 (Amisulpride for IV Injection) as Treatment of Established Post-operative Nausea and Vomiting, in Patients Who Have Had Prior Prophylaxis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Dec 2023

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At a glance

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

    • Most Recent Events

    • 06 Dec 2023 According to Eagle Pharmaceuticals Media Release, post hoc analysis results from this trial will be presented at a the 77th PGA (PostGraduate Assembly in Anesthesiology)
    • 06 Dec 2023 Results of post hoc analysis of pivotal trials published in the Eagle Pharmaceuticals Media Release
    • 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.

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