UK-based specialist pharmaceutical company Acacia Pharma has reported a positive outcome from the Phase III trial of BAREMSIS to treat post-operative nausea and vomiting (PONV).
Formerly known as APD421, BAREMSIS is an intravenous formulation of amisulpride that acts as a selective dopamine antagonist.
The Phase III trial involved 568 patients suffering from nausea or vomiting post surgery and had not received any prophylactic antiemetics.
It was primarily focused to achieve a successful resolution of the episode of PONV within the 24-hour period after treatment, meaning patients will not experience a recurrence of vomiting or need further antiemetic rescue.
Results suggested that both doses of BAREMSIS brought a significant improvement in the complete response rate when compared to placebo with the magnitude of effect remaining consistent with previous trial results.
Acacia Pharma CEO Dr Julian Gilbert said: "We are delighted with this 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."
The company is currently conducting the second pivotal Phase III study of BAREMSIS, which is treating surgical patients with PONV symptoms despite receiving prior prophylaxis.