13 December 2021
Acacia Pharma Announces Successful Completion of BARHEMSYS® Post-approval Requirement Study in Patients with Severe Renal Impairment
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Click here for the NL version
Cambridge, UK and Indianapolis, US – 13 December 2021: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or cancer chemotherapy, announces the successful completion of its post-approval requirement clinical trial investigating the effects of BARHEMSYS® (amisulpride injection) in individuals with severe renal impairment.
The study showed no clinically relevant difference in the pharmacokinetics, electrocardiogram (ECG) parameters or safety profile of BARHEMSYS between individuals with or without severe renal impairment. No adverse events were recorded in any subject.
The clinical trial was required by the US Food and Drug Administration (FDA) as part of the February 2020 approval of BARHEMSYS for the prevention and treatment of postoperative nausea and vomiting (PONV). It was conducted at a specialist Phase 1 unit in Florida and enrolled six subjects with severe renal impairment (defined as an estimated glomerular filtration rate below 30 mL/min/1.73 m2) and six matched healthy volunteers. Participants received a single 10 mg intravenous dose of BARHEMSYS, followed 24 hours later by a single 10 mg oral dose of the active ingredient, amisulpride.
“We are pleased to have completed this study in a timely fashion, despite the challenges associated with running clinical trials during the COVID-19 pandemic, and are delighted with the uniformly positive results,” commented Dr. Gabriel Fox, Acacia Pharma’s Chief Medical Officer. “We plan to submit the data to FDA as soon as possible and believe the results will support amendment of the BARHEMSYS label to include use in patients with severe renal impairment. We also plan to publish the results of the study in a peer-reviewed journal during 2022. We extend our thanks to the 12 individuals who took part in the study and to the healthcare professionals who assisted in its conduct.”
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 anesthetic gases and opioid painkillers and is particularly common following gynecological, 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, even worse than pain.1
BARHEMSYS is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist, which Acacia Pharma has developed and protected for the management of PONV.
BARHEMSYS is approved in the US and indicated in adults for:
• treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis
• prevention of PONV, either alone or in combination with an antiemetic of a different class
Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
+44 1223 919760 / +1 317 505 1280
Frazer Hall, Mark Swallow, David Dible
+44 20 7638 9571
Media in Belgium and the Netherlands
Chris Van Raemdonck
+32 499 58 55 31
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy. The Company has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.
Barhemsys® (amisulpride) injection is a selective dopamine (D2 and D3) receptor antagonist approved and available in the US for the treatment and prevention of postoperative nausea & vomiting (PONV) in adult patients.
Please see full prescribing information, including Important Safety Information, at www.BARHEMSYS.com
Byfavo® (remimazolam) for injection, is an IV benzodiazepine sedative approved and available in the US for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less. Byfavo is in-licensed from Paion UK Limited for the US market.
Please see full prescribing information, including Important Safety Information and Boxed Warning, at www.BYFAVO.com
APD403 (intravenous and oral amisulpride), a selective dopamine antagonist 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 has its US headquarters in Indianapolis, IN and its R&D operations are centred in Cambridge, UK. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.
This release is intended for investors and media only.
Forward looking statement
This announcement includes forward-looking statements, which are based on current expectations and projections about future events. These statements may include, without limitation, any statements preceded by, followed by or including words such as “believe”, “expect”, “intend”, “may”, “plan”, “will”, “should”, “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements may and often do differ materially from actual results. These forward-looking statements are subject to risks, uncertainties and assumptions about the Company and its subsidiaries and investments, including, among other things, the development of its business, trends in its operating industry, and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's business, results of operations, financial position, prospectus, growth or strategies and the industry in which it operates. Save as required by law or applicable regulation, the Company and its affiliates expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise. Forward-looking statements speak only as of the date they are made.
1. Gan TJ, et al. Anesth Analg. 2014;118(1):85-113