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.
Based on a press release from Acacia Pharma Group.