The Food and Drug Administration (FDA) has approved Barhemsys (amisulpride; Acacia Pharma) for the prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class and for the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.
The active ingredient of Barhemsys is amisulpride, a selective dopamine-2 and dopamine-3 receptor antagonist. The drug is administered as a single intravenous dose infused over 1-2 minutes at the time of induction of anesthesia (for prevention) or in the event of nausea and/or vomiting after a surgical procedure (for treatment).
The approval of Barhemsys was based on data from 4 double-blind, placebo-controlled trials evaluating the therapy for both prevention and treatment of PONV.
In the prevention trials, Barhemsys was evaluated as both a monotherapy and in combination with 1 other intravenously administered, non-dopaminergic antiemetic (ondansetron, dexamethasone or betamethasone). Results showed a complete response (defined as the absence of any episode of emesis or use of rescue medication within the first 24 hours postoperatively) was achieved in 44% (n=78) of patients who received Barhemsys monotherapy vs 33% (n=54) of those who received placebo (difference: 12%; 95% CI, 2-22). When administered in combination with another antiemetic, 58% (n=330) of patients in the Barhemsys group achieved complete response compared with 47% (n=268) of patients in the placebo group (difference: 11%; 95% CI, 5-17). The most common adverse reactions reported in these trials included increased blood prolactin concentrations, chills, hypokalemia, procedural hypotension, and abdominal distention.
The treatment trials included both patients experiencing PONV after general anesthesia and elective surgery who had not received prior PONV prophylaxis as well as those who had received and failed PONV prophylaxis with an antiemetic of another class. Among patients who had not received prior prophylaxis, 31% (n=59) achieved complete response with Barhemsys (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]) compared with 22% (n=39) with placebo (difference: 10%; 95% CI, 1-19). Among those who received prior prophylaxis, 42% (n=96) had a complete response with Barhemsys vs 29% (n=67) with placebo (difference: 13%; 95% CI, 5-22). The most common adverse reaction reported in these trials was infusion site pain.
Regarding safety, Barhemsys can cause dose- and concentration-dependent prolongation of the QT interval and should therefore be avoided in patients with congenital long QT syndrome or in those taking droperidol.
Commenting on the approval, Mike Bolinder, Acacia Pharma’s CEO, said, “Our goal is for Barhemsys to become established as the new standard of care in the US for the treatment of PONV in patients who have failed standard prophylaxis, the area of highest unmet need. The results of our extensive clinical program also allow us to offer Barhemsys as an option for the prevention of PONV in higher-risk patients and settings, where combination prophylaxis can be valuable.”
Barhemsys is supplied in 5mg/2mL single-dose vials and is expected to be available in the second half of 2020.
For more information visit acaciapharma.com.