FDA provides fresh boost for Acacia Pharma’s US launch
The US FDA has approved a second supplier for the active pharmaceutical ingredient for BARHEMSYS® – a treatment and preventative for PONV (postoperative nausea and vomiting) from Cambridge life science technology business Acacia Pharma.
BARHEMSYS was approved for the treatment and prevention of PONV in the US in February 2020. The fresh supplier approval significantly increases the company’s commercial product stock levels ahead of the US launch of BARHEMSYS.
The company anticipates the approval of a second supplier will support its ability to provide a continuous, high-quality product supply to meet the anticipated ongoing demand.
CEO Mike Bolinder said: “We are very pleased to have received approval from the FDA for our second supplier of API for BARHEMSYS as we continue to make good progress with our preparations for its US launch.
“We believe there will be strong demand for BARHEMSYS as US healthcare institutions seek to address surgical backlogs created by the coronavirus crisis.
“The strengthening of our supply chain and increase in our available commercial inventory will be important in helping us meet that demand, providing our customers with consistent and timely access to BARHEMSYS for their patients.”
BARHEMSYS® is a low dose intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride, which Acacia Pharma has developed and protected for the management of PONV.
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy.
It says it has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.
BARHEMSYS® is its maiden product and a US launch is planned for the second half of 2020.
Acacia Pharma is based in Cambridge UK and its US operations are centred in Indianapolis. The company is listed on the Euronext Brussels exchange.