Editorial on Positive Data for BARHEMSYS® Treatment of Post-Operative Nausea & Vomiting (PONV) Published in Anesthesia & Analgesia
Cambridge, UK and Indianapolis, US – 12 July 2019: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) welcomes an editorial published in the leading peer-reviewed journal Anesthesia & Analgesia, accompanying the print publication of results from its positive Phase 3 clinical trial of BARHEMSYS® (intravenous amisulpride) as treatment of post-operative nausea & vomiting (PONV) in patients who had not received prior prophylaxis*.
In their editorial, entitled “Amisulpride: A New Dopamine Antagonist for Treatment of Postoperative Nausea and Vomiting”, Professor Gan and Dr Mouch, of the Department of Anesthesia at Stony Brook University Hospital, New York, highlight the positive data published by Candiotti et al in the same issue of the journal and comment that there is now “favorable evidence that amisulpride may be effective in both the prophylaxis and treatment of postoperative nausea and vomiting.”
The authors further review safety and cardiac conduction data published on amisulpride and conclude that it has “a similar adverse event profile compared to placebo” and “lower risks of corrected QT interval prolongation at clinically relevant doses.”
Dr Gabriel Fox, Chief Medical Officer of Acacia Pharma, welcomed the editorial: “We are delighted that Professor Gan and Dr Mouch have identified BARHEMSYS as worthy of an editorial in Anesthesia & Analgesia. We agree with their observation that ‘there remain few options for treatment after [PONV] has manifested, especially in those who have already received prophylaxis.’ We remain committed to bringing BARHEMSYS to patients as soon as possible and hope to secure its approval from the United States Food & Drug Administration in the first quarter of next year.”
Gan TJ and Mouch CM. Amisulpride: A New Dopamine Antagonist for Treatment of Postoperative Nausea and Vomiting. Anesth Analg 2019; 128(6):1074-1076.
Candiotti KA, Kranke P, Bergese SD, et al. Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Amisulpride as Treatment of Established Postoperative Nausea and Vomiting in Patients Who Have Had No Prior Prophylaxis. Anesth Analg 2019; 130:1098-1105.
*Note that the data from this Phase 3 study were previously published online in a pre-print e-publication in September 2018.
- Miranda Parker