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Amisulpride has
received United States Food and Drug Administration (US FDA) approval to manage
patients with postoperative nausea and vomiting (PONV).
Amisulpride (a selective dopamine-2 and dopamine-3 receptor antagonist) has received US FDA acceptance for managing PONV in individuals who have received antiemetic prophylaxis with a different class agent or have not received prophylaxis therapy. It may also be utilized for preventing PONV, either alone or in combination with a distinct category of antiemetic drugs.
At the time of anesthesia induction (PONV prevention) or in the case of nausea and/or vomiting after surgery (PONV management), this drug is generally given intravenously as a single dose over one-two minutes. Its FDA approval was based on data gathered from four double-blind, placebo-controlled clinical trials investigating both PONV prevention and treatment.
In the prevention studies, this dopamine antagonist was assessed as both a monotherapy and in combination with one other intravenously given, non-dopaminergic antiemetic drug (dexamethasone, ondansetron, or betamethasone).
Compared to patients receiving placebo, a greater no. of patients receiving amisulpride monotherapy witnessed complete response (defined as the absence of any episode of emesis or use of rescue medication within the first 24 hours postoperatively), as shown in the following table:
Compared to patients in the placebo group, a greater no. of patients receiving amisulpride monotherapy in combination with another antiemetic achieved a complete response, as depicted in the following table:
Hypokalemia, elevated blood prolactin concentrations, chills, procedural hypotension, and abdominal distention were the most commonly reported adverse reactions. The treatment studies incorporated both patients experiencing PONV after general anesthesia and elective surgery who had not received prior PONV prophylaxis and also those who had received and failed PONV prophylaxis with an antiemetic drug of another class.
Compared to the placebo group, a higher number of patients not receiving prior prophylaxis and patients receiving prior prophylaxis attained a complete response with amisulpride (defined as the absence of any episode of emesis or use of rescue medication within the first 24 hours after treatment [excluding emesis within the first 30 minutes]), as depicted in the following table:
The infusion site pain was the most commonly noted adverse reaction in these trials. Regarding safety, amisulpride can lead to dose and concentration-dependent prolongation of the QT interval. Thus, it is strictly contraindicated in patients taking droperidol and in patients having congenital long QT syndrome.
Notably, the primary aim is to establish amisulpride as the standard of therapeutic care in the United States for managing PONV in individuals who have failed standard prophylaxis therapy (the highest area of unfulfilled need). The promising results of the extensive analysis permit amisulpride to be an alternative for preventing PONV in elevated-risk patients and clinical settings, where combination prophylaxis can be remarkably advantageous.
Amisulpride is supplied in 5mg/2mL single-dose vials and is anticipated to be
commercially available in the second half of 2020.
MPR
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