US FDA approves amisulpride injection for treatment of post-op nausea

March 5, 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 intravenous formulation of the selective dopamine D2 and D3 antagonist (2.5 mg/mL). The New Drug Application (NDA) submitted by Acacia Pharma for amisulpride injection, 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 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 the product in 2H 2020.

The most common side effects observed across the four pivotal studies reported in at least 2% of adult patients who received Barhemsys and at a higher rate than placebo were: infusion site pain (6% vs 4% with placebo), chills (4% vs 3%), hypokalemia (4% vs 2%), procedural hypotension (3% vs 2%), and abdominal distension (2% vs 1%). Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of Barhemsys-treated patients had increased blood prolactin reported as an adverse reaction compared to 1% (1/166) of placebo-treated patients.