28 January 2019
Editorial in Anesthesiology on Positive Data for BARHEMSYS™ PONV Rescue Treatment
Cambridge, UK and Indianapolis, US – 28 January 2019: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) welcomes an editorial published in the leading 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 randomized 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 anesthesia,” Drs Darvall and Leslie highlight “a lack of high-quality, randomized 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.
Acacia Pharma Group plc
Julian Gilbert, CEO
Christine Soden, CFO
+44 1223 919760
Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Shabnam Bashir, David Dible
+44 20 7638 9571
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 commercialisation 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. A New Drug Application (NDA) for BARHEMSYS is under review by the US Food and Drug Administration (FDA). 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 its US operations are centred in 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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