FDA Approves Barhemsys, New Option for Postop Nausea and Vomiting

Megan Brooks

February 27, 2020

The US Food and Drug Administration (FDA) has approved amisulpride injection (Barhemsys, Acacia Pharma) for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults.

Amisulpride injection is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed prior prophylaxis using current standard of care.

For prevention of PONV, amisulpride can be used either alone or in combination with an antiemetic of a different class.

An estimated 16 million surgical patients each year in the US suffer from PONV despite receiving prophylaxis.

In four phase 3 trials involving surgical patients and healthy volunteers, amisulpride injection "demonstrated significant benefits in the treatment and prevention of PONV," Gabriel Fox, Acacia Pharma's chief medical officer, said in a news release announcing approval.

In one randomized, double-blind, placebo-controlled study involving 465 patients who had failed the most commonly used antiemetic prophylaxis, a single 10 mg dose of amisulpride injection was significantly more effective than placebo at treating patients (42% vs 29%; P = .003).

In a separate double-blind, randomized, placebo-controlled study involving 1147 patients at the high risk for PONV (Apfel score 3 or 4), a single 5 mg dose of the drug in combination with another antiemetic significantly improved protection from PONV compared to placebo plus another antiemetic (58% vs 47%; P < .001).

The most common side effects observed across phase 3 testing, reported in at least 2% of adult patients who received amisulpride injection 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 distention (2% vs 1%).

Serum prolactin concentrations were measured in one prophylaxis study, with 5% of amisulpride-treated patients showing increased blood prolactin compared with 1% of placebo-treated patients.

"PONV remains a major problem for surgical patients and there have been few therapeutic advances over the past 20 years," TJ Gan, MD, chairman of the Department of Anesthesiology at Stony Brook University in New York, said in the news release.

"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," said Gan.

The company expects to launch amisulpride injection in the second half of this year.

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