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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Oct 2021

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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

    • 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.
    • 07 Oct 2014 Top-line results reported in an Acacia media release.
    • 07 Oct 2014 Primary endpoint (significantly lower proportion of amisulpride vs placebo recipients with no PONV in postoperative 24h) has been met, according to an Acacia media release.
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