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Acacia Pharma’s antiemetic drug prevents post-op nausea and vomiting
12 August 2016 • Author: Acacia Pharma
Acacia Pharma’s phase 3 trial, comprised of 568 patients, compared two doses of Baremsis (amisulpride injection, formerly APD421), a dopamine D2/D3 antagonist antiemetic, against placebo in patients with established nausea and/or vomiting after surgery (PONV), who had not previously received any prophylactic antiemetics.
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.
In the meantime, a second Phase 3 study into surgical patients who develop PONV despite receiving prior prophylaxis is ongoing.
The results from both studies 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.
Dr Julian Gilbert, Acacia Pharma’s CEO commented, “We are delighted with these data; it confirms our confidence in the dopamine antiemetic mechanism of action, and that Baremsis is effective at treating, as well as preventing, PONV. 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.”
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