Amisulpride IV for treatment of post-op nausea

April 4, 2020 0 By FM

Acacia Pharma Group plc has announced that the US FDA has approved amisulpride injection (Barhemsys) for the prevention and treatment of postoperative nausea and vomiting (PONV) in adult patients.

The New Drug Application (NDA) submitted by Acacia Pharma for the intravenous formulation of the selective dopamine D2 and D3 antagonist (2.5 mg/mL) which included four positive phase 3 studies, contained data gathered from more than 3,300 surgical patients and healthy volunteers. 

The approval for amisulpride injection 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 the drug and plans to launch the product in 2H 2020.