Baremsis filed with FDA for post-operative nausea & vomiting.
Baremsis (amisulpride injection, formerly APD421) has been filed for the management of post-operative nausea & vomiting (PONV) and accepted by the FDA. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of 5th October 2018 to complete its review.
The NDA submission includes data from four positive Phase III studies, including the first ever randomised, controlled trial to show successful treatment of active PONV in patients who have failed prior prophylaxis. More than 3,300 surgical patients and healthy volunteers were enrolled in the Baremsis clinical development programme. If approved, Baremsis would be the first antiemetic with an indication for rescue treatment of PONV after failed prophylaxis, and combination prophylaxis of PONV with standard antiemetics.
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