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.
Dr Julian Gilbert, Acacia Pharma’s CEO 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.”