Positive results have been reported from a pivotal phase 3 study of low-dose amisulpride injection (Baremsis, Acacia Pharma Group) for the treatment of established postoperative nausea and vomiting (PONV). In Europe, amisulpride is indicated for the management of psychoses and is given at high doses in oral form. The treatment is not available for any use in the United States.
The pivotal phase 3 compared two doses of amisulpride, a dopamine D2/D3 antagonist antiemetic, with placebo in patients with established nausea and/or vomiting after surgery who had not received prophylactic antiemetics. The study involved 568 subjects in the U.S., Canada, France, and Germany. The trial’s primary endpoint was the successful resolution of the episode of PONV (i.e., no recurrence of vomiting or a requirement for further antiemetic rescue) in the 24-hour period after treatment, which was considered to be a complete response. Both doses of amisulpride injection significantly improved the complete response rate compared with placebo (P < 0.025).
A second pivotal phase 3 study of low-dose amisulpride injection in surgical patients who developed PONV despite having received prophylaxis is ongoing. Acacia Pharma has already presented late-stage data on the efficacy of amisulpride injection in preventing PONV, alone and in combination with other antiemetics. The results from these studies, along with the new findings, will complete the efficacy package that the company plans to submit to the FDA as part of its new drug application, seeking approval of low-dose amisulpride injection for the treatment and prophylaxis of PONV alone and in combination.
PONV is a common complication of surgery. In untreated patients, the incidence of vomiting is approximately 30%; the incidence of nausea is approximately 50%; and the PONV rate in high-risk surgical patients can be as high as 80%. PONV is reported by patients as one of the most troublesome of all postoperative complications.
Acacia Pharma is also developing amisulpride injection for the prevention of chemotherapy-induced nausea and vomiting.
Source: Acacia Pharma Group; August 12, 2016.