FDA Approves PONV Rescue Treatment for Patients With Prior Prophylaxis Failure

FDA News release

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.

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.