FDA Approves PONV Rescue Treatment for Patients With Prior Prophylaxis Failure

Anesthesiology News

The FDA approved amisulpride (Barhemsys, Acacia Pharma Group) for the treatment of postoperative nausea and vomiting (PONV) in patients who have failed previous antiemetic prophylaxis, according to a release from the company.

The treatment is also approved for the prevention of PONV, either alone or in combination with an antiemetic of a different class.

“PONV remains a major problem for surgical patients, and there have been few therapeutic advances over the past 20 years,” said Tong Joo (T.J.) Gan, MD, a professor and the Distinguished Endowed Chair of the Department of Anesthesiology at Stony Brook University, in New York, and a member of the Anesthesiology News editorial advisory board. “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.”

Barhemsys is an IV formulation of the selective dopamine D₂ and D₃ antagonist amisulpride (2.5 mg/mL). The New Drug Application included four phase 3 studies, which contained data on more than 3,300 surgical patients and healthy volunteers.

In one randomized, double-blind, placebo-controlled study of patients who had failed prior antiemetic prophylaxis, a single 10-mg dose of amisulpride (n=230) was significantly more effective than placebo (n=235) at treating patients (42% vs. 29%; P=0.003).

It is estimated that 16 million surgical patients suffer from PONV each year in the United States despite receiving prophylaxis, according to the company’s release.

Based on a press release from Acacia Pharma Group.