Baremsis is filed at FDA for post-operative nausea & vomiting treatment.
Acacia Pharma Group Ltd announces that the New Drug Application (NDA) for Baremsis (amisulpride injection, formerly APD421) for the management of post-operative nausea & vomiting (PONV), has been accepted for filing by the FDA.
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.
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