Barhemsys (Amisulpride): The Newest Drug for Post-Operative Nausea and Vomiting
On February 26th, 2020 the FDA approved Barhemsys (amisulpride) for the prevention of post-operative nausea and vomiting (PONV) in adult patients who received anesthesia in elective surgeries.
Background
Post-operative nausea and vomiting (PONV) is used to describe any nausea, retching, or vomiting occurring in a patient within 24–48 hours of surgery. PONV occurs in about 30% of all post-operative patients but soars to 80% for high-risk patients. With its prevalent occurrence and overall unpleasant outcome, PONV is one reaction many patients openly express to avoid and are willing to fork over more money to prevent. Patients also tend to rate PONV worse than post-operative pain. From a pharmaceutical manufacturer standpoint, the desire to develop PONV treatment and preventative measures could be considered at a high.
Current treatment strategies for PONV include medications such as dexamethasone, ondansetron, and scopolamine. All of these medications can be readily found in a hospital pharmacy but not one of these medications is completely effective at preventing PONV.
Barhemsys
Barhemsys (amisulpride) is a dopamine-2 (D2) agonist indicated for the prevention of PONV, either alone or in combination with an antiemetic of a different class, or for the treatment of PONV in patients who have been given an antiemetic prophylaxis agent of a different class or have not received prophylaxis. Barhemsys comes as an intravenous injection dosed at 5mg for PONV prevention and 10 mg for PONV treatment. For both indications, it is to be infused for 1–2 minutes at the time of induction of the given anesthesia.
Clinical Trials
Four trials were performed evaluating Barhemsys. Two of those trials focused on the efficacy of Barhemsys prevention while the other two focused on treatment. In the preventative studies, Barhemsys was found to be 12% (study 1) and 11% (study 2) more effective at preventing PONV than placebo. For the treatment studies, Barhemsys was found to be 10% (study 3, no prophylaxis) and 13% (study 4, prior prophylaxis) more effective than placebo at PONV treatment. No trials have currently been completed comparing Barhemsys efficacy to the current antiemetic therapy options.
Risks
While Barhemsys showed promise, granting it the FDA approval, Barhemsys still is accompanied by the increased risk of QT prolongation, much like its counterpart ondansetron. Due to this dose- and concentration-dependent prolongation, dosing must be followed adequately, and ECG monitoring should be done on patients with pre-existing arrhythmias or more broadly, those at increased risk.
Conclusion
Barhemsys may be on its way to becoming a staple in every hospital pharmacy, but with ondansetron and dexamethasone’s minimal cost, they will continue to dominate the PONV treatment approach. Barhemsys will need to push more trials forward comparing it to the current treatment options if it wants to expedite its way to the top.
References
Acacia Pharma Inc. (2020). Barhemsys: Full Prescribing Information. Indianapolis, IN: Author.
Choi, Sung Uk. “Is Postoperative Nausea and Vomiting Still the Big ‘Little’ Problem?” Korean Journal of Anesthesiology, The Korean Society of Anesthesiologists, Feb. 2016, www.ncbi.nlm.nih.gov/pmc/articles/PMC4754258/.
Gan T, Sloan F, Dear Gde L, El-Moalem HE, Lubarsky DA. How much are patients willing to pay to avoid postoperative nausea and vomiting? Anesth Analg. 2001;92:393–400.
Lexicomp. Amisulpride: Drug information. In: UpToDate, Post T, (ed), UpToDate, Waltham, MA: Accessed April 8, 2020.
van den Bosch JE, Bonsel GJ, Moons KG, Kalkman CJ. Effect of postoperative experiences on willingness to pay to avoid postoperative pain, nausea, and vomiting. Anesthesiology. 2006;104:1033–1039.
