US regulators have accepted for review Cambridge, UK-based Acacia Pharma’s application for post-operative nausea and vomiting (PONV) drug Baremsis.
PONV is a common complication of surgery that is not only distressing to patients but also increases healthcare costs, as it can have a detrimental impact on surgical outcomes and significantly impede the post-operative recovery process.
In untreated patients, the incidence of vomiting is around 30 percent, while that of nausea is around 50 percent.
Surgical patients at moderate or high risk of PONV are given prophylactic antiemetics prior to surgery, with standard-of-care based upon 5HT3 antagonists and corticosteroids, but up to 40 percent still develop the condition and thus need further treatment with a difference class of antiemetic.
Baremisis (amisulpride) is a low dose intravenous formulation of the marketed dopamine antagonist amisulpride, which Acacia has repurposed for the completely new, patent-protected use of management of PONV.
The filing includes data from four Phase III studies, including the first ever randomised, controlled trial to show successful treatment of active PONV in patients who have failed prior prophylaxis, the firm noted.
“Our goal is for Baremsis to be the first drug specifically approved for the treatment of PONV in patients who have failed prophylaxis, an area of high unmet need, and to become established as the new standard of care,” said Julian Gilbert, Acacia’s chief executive.
“The broad and unique label we have targeted also includes prophylaxis of PONV, alone and in combination with other anti-emetics.”