Acacia Pharma’s new cancer care injection approved in Europe

pharmafile | September 29, 2021 | News story | Research and Development  

Biopharmaceutical company Acacia Pharma Group plc (Acacia Pharma) has announced that its Marketing Authorisation Application (MAA) for BARHEMSYS® (amisulpride injection) has been submitted and validated, and is now under formal review in major European markets. The review is forecasted to be completed by 2022.

Acacia Pharma is focused on developing and commercialising novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or cancer chemotherapy.

BARHEMSYS is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist. It is the company’s first product, available in the US for the management of postoperative nausea and vomiting (PONV). It was first approved in February 2020 by the FDA, and it became commercially available in August that year.

PONV is a common complication of surgery, associated with the use of anaesthetic gases and opioid painkillers. It occurs in approximately 30% of surgical patients and up to 80% of high-risk patients.

BARHEMSYS is indicated in adults for the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis. It is also used for the prevention of PONV, either alone or in combination with an antiemetic of a different class.

The MAA submission includes data from four positive Phase III studies investigating BARHEMSYS, including the first ever randomised, controlled trial to show successful treatment of active PONV in patients who failed prior prophylaxis.

Over 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 commercialising 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.”

Lina Adams

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