Acacia Pharma announced positive data from the Phase 3 study of Baremsis (amisulpride) for the potential treatment of post-operative nausea & vomiting (PONV).
The Phase 3 study was a placebo-controlled trial evaluating two doses of Baremsis in patients with established PONV who had not previously received any prophylactic antiemetics. The primary endpoint was complete response, defined as the successful resolution of PONV episodes (no recurrence of vomiting or requirement for further antiemetic rescue) in the 24-hour post-treatment period.
Study findings showed that both doses of Baremsis significantly improved the complete response rate when compared to placebo (P<0.025). Results from this study validate the results from previous trials, showing that Baremsis is effective at treating, in addition to, preventing PONV. Detailed data will be presented at upcoming scientific meetings and submitted for publication.
An additional Phase 3 study for Baremsis is currently ongoing for the treatment of PONV in surgical patients who failed prior prophylaxis therapy. Successful completion and results from these studies will support the submission for a New Drug Application (NDA) of Baremsis for the treatment and prophylaxis of PONV alone and in combination with standard antiemetics.
Baremsis (amisulpride), formerly APD421, is a novel, injectable, dopamine D2/D3 antagonist antiemetic.
For more information visit Acaciapharma.com.