25 April 2019
Positive Phase 3 BARHEMSYS® Rescue Treatment Data to be Presented at ASER 2019
Cambridge, UK and Indianapolis, US – 25 April 2019: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) announces that additional data and analyses from its positive Phase 3 clinical trial of BARHEMSYS® (intravenous amisulpride) as a rescue treatment of established post-operative nausea & vomiting (PONV) will be presented today in a poster at the 2019 Annual Congress of Enhanced Recovery and Perioperative Medicine in Washington, DC (25-27 April 2019). Primary study data were previously published (online-first in 2018) by Habib et al. in Anesthesiology (Ref. 1)
The Phase 3 rescue treatment trial compared a single 5 or 10 mg dose of BARHEMSYS, a dopamine D2/D3 antagonist antiemetic, against placebo in patients with established nausea and/or vomiting after surgery, who had previously received prophylactic antiemetics. The double-blind study randomised 702 adult patients and was the first major study to investigate rescue with a different mechanistic class of antiemetic. The primary endpoint was the successful resolution of the episode of PONV (no recurrence of vomiting or requirement for further antiemetic rescue) for the 24-hour period after rescue treatment: termed a complete response.
The conclusion of the study was that a single 10 mg dose of BARHEMSYS was statistically significantly more effective than placebo for the rescue treatment of PONV (complete response rate 42% vs 29%, p=0.006). Additional post-hoc analysis has shown a similar efficacy benefit for BARHEMSYS regardless of the number of antiemetics that had been given as prior prophylaxis; and that the proportion of patients achieving treatment success with BARHEMSYS 10 mg reduces as the number of baseline PONV risk factors increases. The proportion of patients with one or more adverse events was slightly lower in the group receiving 10 mg BARHEMSYS (43.0%) than placebo (48.1%). The only adverse events occurring in at least 5% of patients in either group were nausea 24 hours or more after treatment (12% with BARHEMSYS 10 mg vs 13% with placebo), flatulence (6% vs 8%), constipation (5% vs 7%), vomiting 24 hours or more after treatment (4% vs 6%), headache (4% vs 7%), infusion site pain (5% vs 4%) and pruritus (4% vs 6%).
A New Drug Application (NDA) for BARHEMSYS, including data from this and three other positive Phase 3 trials, is under review by the US Food and Drug Administration (FDA) with a target action date of 5 May 2019. The extensive clinical trial programme has studied the safety and efficacy of BARHEMSYS for investigational new uses in the treatment of established PONV, whether or not prior prophylaxis was given, and the prevention of PONV, alone or in combination with other antiemetics of a different class.
Details of the poster presentation are:
Abstract title: Amisulpride for the Rescue Treatment of Postoperative Nausea and Vomiting in High-Risk Patients who failed Prophylaxis: Impact of Risk Factors and Number of Prophylactic Agents on Treatment Success
Authors: Ayad, S., Elsharkawy, H., Bichajian, L., Ashburn, C., Fox, G., and Habib, A.
Date/time: Thursday 25 April, 17:30-19:00 Eastern Time
Habib, A.S. et al. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis – A Randomized, Placebo-controlled Phase III Trial. Anesthesiology 2019;130(2):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. PONV has been ranked as the most undesirable of all surgical complications in some patient surveys.
Acacia Pharma estimates that approximately 65 million surgical procedures are conducted in the US each year that are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for high risk prophylactic and rescue treatment comprises an estimated 34 million patients annually.
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