Cambridge, UK – Acacia Pharma Group plc (“Acacia Pharma”), the supportive care company developing products for US and international markets, announces positive results from a pivotal Phase 3 study investigating BAREMSIS™ (amisulpride injection, formerly APD421) for the treatment of established post-operative nausea & vomiting (“PONV”). 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.
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.
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