Phase III trial of Baremsis (amisulpride) demonstrates efficacy in post-operative nausea & vomiting- Acacia Pharma

Acacia Pharma has announced positive results from a Phase III study investigating Baremsis (amisulpride injection, formerly APD 421) in combination with standard antiemetics for the prevention of post-operative nausea & vomiting in high-risk patients. The combination trial compared the prophylactic use of Baremsis plus a standard antiemetic (for example ondansetron or dexamethasone) against placebo plus a standard antiemetic. The primary endpoint was complete response, defined as no vomiting or retching and no requirement for antiemetic rescue medication in the first 24 hours after surgery. Baremsis significantly improved the complete response rate when added on top of a standard antiemetic compared to placebo and a standard antiemetic (57.7% vs 46.6%).

In addition, all secondary efficacy endpoints, including the rate of vomiting, nausea and use of rescue medication, were also met. The safety profile of Baremsis was excellent. No toxicities of note were seen and the profile of adverse events and laboratory abnormalities was as good as placebo. Detailed data will be presented in due course at relevant scientific meetings and submitted for publication in a peer-reviewed journal.