An overview of intravenous amisulpride as a new therapeutic option for the prophylaxis and treatment of postoperative nausea and vomiting

ABSTRACT

Introduction

Current therapies of postoperative nausea and vomiting (PONV) are based on a combination of antiemetics from different pharmacological classes. Dopamine receptor antagonists are one of the cornerstones of such multimodal antiemetic approach, with droperidol being the best studied representative of this group. Droperidol’s use has significantly declined after the FDA’s black-box warning in 2001 due to its QT-prolonging properties. Amisulpride is a promising antiemetic agent which could fill this gap.

Areas covered

In this review, the authors discuss the pharmacological profile as well as clinical safety and efficacy of intravenous amisulpride and its relevance in the management of PONV. The article is based on a Medline, ClinicalTrials.gov, and Cochrane Library search for studies on amisulpride conducted so far.

Expert opinion

Promising clinical results on Barhemsys®, an intravenous formulation of amisulpride, make it a potential future drug of choice from the dopamine receptor antagonist group, replacing droperidol after its safety concerns. Amisulpride’s success on the market will mostly be determined by its cost-effectiveness and it will likely find a brighter use on the US-market, where the black-box warning led to droperidol’s withdrawal, while in many European countries, droperidol is still being used as an antiemetic.

KEYWORDS:

• Antiemetic
• postoperative nausea and vomiting (PONV)
• amisulpride
• benzamide
• dopamine receptor antagonists
• droperidol

Article highlights

• Prophylaxis and treatment of postoperative nausea and vomiting requires a multimodal approach, including various antiemetics acting at different receptor sites.

• FDA’s black box warning for droperidol due to QT-prolongation alienated anaesthesiologists and decreased the use of this potent dopamine2-antagonist.

• An aqueous solution of amisulpride (Barhemsys(R)), an alternative D2-antagonist with a superior safety profile will soon be available.

• Depending on economic considerations this drug has the potential to substitute droperidol within a multimodal antiemetic concept.

Box 1. Drug summary box.

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Declaration of interest

T Koch declares that he has received honoraria from Ratiopharm GmbH, Germany while L Eberhart has received honoraria from Grunenthal, Fresenius-Kabi GmbH, and Ratiopharm GmbH. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

One referee declares that he has served as an investigator for two of the Acacia multicenter trials on amisulpride and received research grant funding for their participation. Another referee declares that in the past 3 years, he has received honoraria as a consultant/advisor and/or for lectures from LB Pharma, Otsuka, Lundbeck, Boehringer Ingelheim, LTS Lohmann, Janssen, Johnson & Johnson, Teva, Merck Sharp and Dohme, Sandoz, Sanofi, Angelini, Recordati, Sunovion, and Geodon Richter. Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Additional information

Funding

This manuscript was not funded.