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FDA accepts NDA for post-operative nausea, vomiting drug
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The FDA has accepted a new drug application for Baremsis for the management of post-operative nausea and vomiting, according to the manufacturer.
The FDA Prescription Drug User Fee Act (PDUFA) target action date is Oct. 5, 2018, according to the press release.
Baremsis (formerly APD421, Acacia Pharma) is a low dose intravenous formulation of the dopamine antagonist amisulpride, which the manufacturer has repurposed for the management of post-operative nausea and vomiting. The drug is currently administered orally at high doses to treat psychoses outside of the U.S., per the press release.
If approved, it would be the first antiemetic available for use as a rescue treatment of post-operative nausea and vomiting after failed prophylaxis, the release noted.
Acacia Pharma filed its NDA after Baremsis showed positive results in phase 3 clinical studies, including a randomized controlled trial with 3,300 participants.
“Our goal is for Baremsis to be the first drug specifically approved for the treatment of [post-operative nausea and vomiting] in patients who have failed prophylaxis, an area of high unmet need, and to become established as a new standard of care,” Julian Gilbert, MD, CEO of Acacia Pharma said in the press release. “The broad and unique label we have targeted also includes prophylaxis of [post-operative nausea and vomiting], alone and in combination with other anti-emetics.” – by Alex Young
Disclosures: Gilbert is employed by Acacia Pharma.