Positive results have been reported from a phase III study investigating the dopamine antagonist amisulpride (Baremsis, Acacia Pharma) in combination with standard antiemetics for the prevention of post-operative nausea and vomiting (PONV) in high-risk patients.
The study compared the prophylactic use of amisulpride injection plus a standard antiemetic (e.g., ondansetron or dexamethasone) with placebo injection plus a standard antiemetic. The study’s primary endpoint was a complete response (CR), defined as no vomiting or retching and no requirement for antiemetic rescue medication during the first 24 hours after surgery.
The study, conducted in the U.S. and Europe, enrolled 1,204 surgical patients with three or four risk factors for PONV, of whom 1,147 were evaluable.
Amisulpride significantly improved the CR rate when added to a standard antiemetic compared with placebo and a standard antiemetic (58% versus 47%, respectively; P = 0.0002). In addition, all secondary efficacy endpoints, including the rates of vomiting, nausea, and use of rescue medication, were met.
Baremsis consists of a low-dose intravenous formulation of amisulpride that has been repurposed for new, patent-protected use in the management of PONV. Outside the U.S., amisulpride is currently indicated for the management of psychoses and is given at high doses in oral form. The drug is not approved for any uses in this country.
Acacia Pharma believes that low-dose amisulpride injections can be used prophylactically in combination with 5-HT3 receptor antagonists and/or corticosteroids to treat patients at high risk for PONV and to rescue patients that have not responded to PONV prophylaxis with a 5-HT3 receptor antagonist alone or in combination with other drugs.
The company anticipates submitting a new drug application to the FDA in the second half of 2016.
Source: Acacia Pharma; January 5, 2016.