04 January 2018
FDA Acceptance Of NDA Filing For BAREMSIS® For The Management Of PONV
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
Cambridge, UK and Indianapolis, US – 4th January 2018: Acacia Pharma Group Ltd (“Acacia Pharma”), a pharmaceutical company developing and commercialising hospital products for US and international markets, 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 US Food and Drug Administration (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 3 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.
Dr Julian Gilbert, Acacia Pharma’s CEO commented: “We are delighted to have achieved this major milestone for the Company. 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. The broad and unique label we have targeted also includes prophylaxis of PONV, alone and in combination with other anti-emetics. We are now moving forward with our US commercialisation plans to deliver an effective management option for the millions of patients each year suffering from, or at risk of, PONV.”