Acacia Pharma Announces US FDA Approval of BARHEMSYS (amisulpride) for the Treatment and Prevention of Postoperative Nausea and Vomiting (PONV) - Seite 2

Professor TJ Gan, Chairman of the Department of Anesthesiology at Stony Brook University in New York, said: “PONV remains a major problem for surgical patients and there have been few therapeutic advances over the past 20 years. It is often considered by patients to be the most undesirable complication of surgery, even worse than pain. It is therefore very welcome to be able to add BARHEMSYS to the treatment arsenal, especially for rescue treatment of patients failing standard prophylaxis, where we previously had no approved agent.”

“We are delighted that BARHEMSYS has gained FDA approval,” said Acacia Pharma’s Chief Medical Officer, Dr. Gabriel Fox. “BARHEMSYS demonstrated significant benefits in the treatment and prevention of PONV in four pivotal trials. We are grateful to all the clinical investigators, hospital staff and, above all, patients who have made this approval possible through their participation in our clinical development program.”

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 3 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.

In a randomized, double-blind, placebo-controlled study involving patients who had failed the most commonly used antiemetic prophylaxis, a single 10 mg dose of BARHEMSYS (n=230) was significantly more effective than placebo (n=235) at treating patients (42% vs 29%; p=0.003).¹ In a double-blind, randomized, placebo-controlled study in patients at the highest risk of suffering from PONV (Apfel score 3 or 4), a single 5 mg dose of BARHEMSYS in combination with another antiemetic (n=572) significantly improved protection from PONV compared to placebo plus another antiemetic (n=575; 58% vs 47%; p<0.001).⁴