FDA approves Barhemsys to treat post-operative nausea and vomiting (PONV) in a hospital setting- Acacia Pharma.
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Published:28th Feb 2020
Acacia Pharma Group plc 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, announces that the FDA has approved Barhemsys (amisulpride injection) for the prevention and treatment of PONV (post-operative nausea and vomiting) in adult patients. Barhemsys is an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride (2.5 mg/mL). The New Drug Application (NDA) submitted by Acacia Pharma for Barhemsys which included four positive Phase III studies, contained data gathered from more than 3,300 surgical patients and healthy volunteers. The approval for Barhemsys covers the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis and the prevention of PONV, either alone or in combination with an antiemetic of a different class. The Company owns global rights to Barhemsys and intends to directly commercialize the product in the US through its own sales channel, having built critical sales, marketing, medical, and operational infrastructure and capabilities over the past two years. The Company plans to launch Barhemsys in 2H 2020.