Acacia Pharma Group plc welcomes an editorial published in the peer-reviewed journal Anesthesiology, accompanying the print publication of results from its positive Phase 3 clinical trial of BARHEMSYS™ (intravenous amisulpride) as rescue treatment of established post-operative nausea & vomiting (PONV).
In their editorial, Drs Darvall and Leslie, of the University of Melbourne, Australia, comment on the significance of what they describe as “the first randomised placebo-controlled trial proving the effectiveness of a rescue treatment for postoperative nausea and vomiting after failed prophylaxis with a different agent.”
Noting “it is likely that, on any given day, hundreds of thousands of patients worldwide are vomiting, retching, or experiencing nausea after anaesthesia,” Drs Darvall and Leslie highlight “a lack of high-quality, randomised controlled trials of postoperative nausea and vomiting treatment” and summarise the evidence that “rescue treatment after failed prophylaxis with an agent from the same class is ineffective.”
Commending aspects of the trial design, including the distinct and thorough assessment of nausea as well as vomiting, the editorial authors conclude that the study “addresses a huge gap in our clinical evidence base.”
Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer, commented: “We are honoured that a journal as prestigious as Anesthesiology has selected our trial with BARHEMSYS as the basis of an editorial. We thank Drs Darvall and Leslie for their thoughtful and balanced article, in which they clearly highlight the pressing unmet need in treating established PONV after failure of standard prophylaxis. We agree with their observation that many millions of patients are suffering with PONV each year and that more research into effective treatments is urgently required. We remain fully committed to further investigation in this highly important and clinically relevant field.”
Darvall, J.N. and Leslie, K. Pounds of Prevention but Only Ounces of Cure. Anesthesiology 2019; 130:183-185.
Habib, A.S. et al.: Amisulpride for the Rescue Treatment of Postoperative Nausea and/or Vomiting in Patients Failing Prophylaxis: A Randomized, Placebo-controlled Phase III Trial. Anesthesiology 2019; 130:203-212.