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news.Acacia Pharma has unveiled positive results from a pivotal Phase 3 study investigating BAREMSIS (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting (PONV).
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These data further support the efficacy of BAREMSIS which has previously been shown to prevent PONV alone, and in combination with standard anti-emetics in pivotal Phase 3 prophylaxis studies.
Acacia Pharma CEO Dr Julian Gilbert commented: “We are delighted with these data demonstrating that BAREMSIS is safe and effective at treating patients suffering PONV after surgery. It confirms our confidence in the dopamine antiemetic mechanism of action, and that BAREMSIS is effective at treating, as well as preventing, PONV.
“Our objective is to seek approval for BAREMSIS for the treatment and prophylaxis of PONV alone and in combination, which will provide us with a broad and unique label once approved.
“No other antiemetic has a PONV treatment claim following failed prophylaxis with standard antiemetics and no other antiemetic has a combination use claim in PONV prophylaxis.”
This Phase 3 treatment trial compared two doses of BAREMSIS, a novel dopamine D2/D3 antagonist antiemetic, against placebo in patients with established nausea and/or vomiting after surgery, who had not previously received any prophylactic antiemetics.
The study took place in leading institutions in the USA, Canada, France and Germany and recruited 568 patients. The primary endpoint was the successful resolution of the episode of PONV (no recurrence of vomiting or requirement for further antiemetic rescue) in the 24-hour period after treatment, termed a complete response.
Both doses of BAREMSIS significantly improved the complete response rate when compared to placebo (p<0.025), the magnitude of effect was consistent with previous trial results. Detailed data will be presented in due course at relevant scientific meetings and submitted for publication in a peer-reviewed journal.
A second pivotal Phase 3 treatment study of BAREMSIS in surgical patients who develop PONV despite receiving prior prophylaxis is ongoing. Acacia Pharma has already shown BAREMSIS prevents PONV in pivotal Phase 3 prophylaxis studies, alone and in combination with other antiemetics.
The results from these studies, along with the results announced today, will complete the efficacy package Acacia Pharma aims to submit to the US FDA as part of its New Drug Application (NDA), looking to gain approval for BAREMSIS for the treatment and prophylaxis of PONV alone and in combination.