Acacia Pharma gets USFDA nod of BARHEMSYS® (amisulpride) for Treatment, Prevention of PONV

Cambridge and Indianapolis: 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 US Food and Drug Administration (FDA) has approved BARHEMSYS® (amisulpride injection) for the prevention and treatment of PONV in adult patients.

"The approval of our first product represents a significant milestone in Acacia Pharma's evolution into an integrated hospital pharmaceutical company with strong development and commercialization capabilities," commented Mike Bolinder, Acacia Pharma's CEO. "I would like to thank the Acacia Pharma team and stakeholders that have delivered this new treatment option for the millions of adult surgical patients each year suffering from, or at risk of, PONV. Our goal is for BARHEMSYS to become established as the new standard of care in the US for the treatment of PONV in patients who have failed standard prophylaxis, the area of highest unmet need. The results of our extensive clinical program also allow us to offer BARHEMSYS as an option for the prevention of PONV in higher-risk patients and settings, where combination prophylaxis can be valuable. We are on target with our commercial preparations and expect to launch BARHEMSYS in the second half of this year."

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). (ref. 4)

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.

Acacia Pharma's second product, Byfavo™ (remimazolam injection), was recently in-licensed from Cosmo Pharmaceuticals NV and an NDA is currently under review by FDA for use in procedural sedation in adults. The application has a target PDUFA action date of 5 April 2020. Subject to approval, the Company also intends to launch Byfavo in the US during 2020 and to commercialize Byfavo using the same sales and marketing infrastructure.

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