Cambridge, UK and Indianapolis, US – 29 September 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 that its Marketing Authorization Application (MAA) for BARHEMSYS® (amisulpride injection) has been submitted, validated and is now under formal review in major European markets. The review process is expected to be completed by Q3/2022.
BARHEMSYS was approved in February 2020 by the Food and Drug Administration (FDA) for use in the United States to prevent and treat postoperative nausea & vomiting (PONV) and became commercially available in August 2020.
The MAA submission includes data from four positive Phase 3 studies investigating BARHEMSYS, including the first ever randomized, controlled trial to show successful treatment of active PONV in patients who have failed prior prophylaxis. More than 3,300 surgical patients and healthy volunteers were enrolled in the BARHEMSYS clinical development program.
“BARHEMSYS was successfully launched in the US last year via our own commercial infrastructure and we are now making good progress to making it available in Europe for the many millions of surgical patients who suffer from PONV each year,” commented Mike Bolinder, Acacia Pharma’s CEO. “We own global rights to BARHEMSYS and, as we have stated, are pursuing a partnership strategy for commercializing the product outside the US market. We are working diligently to progress international licensing agreements ahead of the product’s anticipated European approval in 2022.”
About PONV
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
About BARHEMSYS®
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 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 prophylaxisprevention of PONV, either alone or in combination with an antiemetic of a different class