FDA Approves Drug for Postoperative Nausea and Vomiting
The US Food and Drug Administration (FDA) approved Barhemsys (amisulpride) for the treatment and prevention of postoperative nausea and vomiting (PONV).
It is the first and only approved antiemetic for the rescue treatment of PONV among surgical patients for whom prior standard-of-care prophylaxis was not effective.
Barhemsys, an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride (2.5 mg/mL), was approved by the FDA following 4 positive phase 3 studies that had included more than 3300 surgical patients and healthy volunteers. In these trials, Barhemsys was shown to be significantly more effective than placebo.
The most commonly reported adverse effects associated with the use of Barhemsys include:
- Infusion site pain (6% vs 4% with placebo)
- Chills (4% vs 3% with placebo)
- Hypokalemia (4% vs 2% with placebo)
- Procedural hypotension (3% vs 2% with placebo)
- Abdominal distension (2% vs 1% with placebo)
“PONV remains a major problem for surgical patients, and there have been few therapeutic advances over the past 20 years,” said TJ Gan, MD, chairman of the Department of Anesthesiology at Stony Brook University in New York, in a press 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 Dr Gan in a press release.
—Christina Vogt
Reference:
Acacia Pharma announces US FDA approval of BARHEMSYS® (amisulpride) for the treatment and prevention of postoperative nausea and vomiting (PONV). News release. Acacia Pharma Group plc. February 27, 2020. https://www.globenewswire.com/news-release/2020/02/27/1991526/0/en/Acacia-Pharma-Announces-US-FDA-Approval-of-BARHEMSYS-amisulpride-for-the-Treatment-and-Prevention-of-Postoperative-Nausea-and-Vomiting-PONV.html.