Positive results have been announced from the fourth and final pivotal study of amisulpride injection (Baremsis, Acacia Pharma Group) for the rescue treatment of patients who develop postoperative nausea and vomiting (PONV) despite having received prior antiemetic prophylaxis. The phase 3, double-blind study compared two doses of amisulpride, a dopamine D2/D3 antagonist antiemetic, with placebo.
The trial recruited a total of 2,285 patients at centers in the United States, Canada, France, and Germany. Of these subjects, 705 (31%) went on to experience PONV and were enrolled into the trial. The primary endpoint was a complete response (CR), defined as the successful resolution of the episode of PONV (i.e., no recurrence of vomiting or a requirement for further antiemetic rescue) during the 24-hour period after rescue treatment. The optimal dose of amisulpride significantly improved the CR rate compared with placebo (P = 0.003).
Acacia Pharma is expected to submit a new drug application to the FDA during the first half of 2017. The company will seek the approval of amisulpride injection for the rescue treatment and prophylaxis of PONV, alone and in combination.
Surgical patients at moderate or high risk of PONV receive prophylactic antiemetics before surgery, with standard-of-care based on 5HT3 (serotonin) antagonists and corticosteroids. However, up to 40% of these patients develop PONV and must be treated with an antiemetic from a different mechanistic class.
Source: Acacia Pharma; February 13, 2017.