Editorial on Positive Data for BARHEMSYS® Treatment of Post-Operative Nausea & Vomiting (PONV) Published in Anesthesia & AnalgesiaSource: OMX
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.
Acacia Pharma Group plc
Julian Gilbert, CEO
Christine Soden, CFO
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PONV is a common complication of surgery, occurring in approximately 30% of surgical patients and up to 80% of high-risk patients. It is associated with the use of anaesthetic gases and opioid pain-killers and is particularly common following gynaecological, abdominal, breast, eye and ear operations, especially those lasting an hour or more.
The Company estimates that approximately 65 million surgical procedures are conducted in the US each year that require injectable analgesia and are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for prophylactic and rescue treatment comprises an estimated 34 million treatment events annually.
PONV has been ranked as the most undesirable of all surgical complications by patients and contributes significantly to patient anxiety and distress. PONV can delay hospital discharge; result in re-admission after in-patient procedures; and lead to day-case patients being admitted to hospital, all of which can result in significantly increased healthcare costs.
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new nausea & vomiting treatments for surgical and cancer patients. The Group has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
The Group's lead project, BARHEMSYS® for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV), has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma is based in Cambridge, UK and Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH. www.acaciapharma.com
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