US FDA backs Acacia progress
Acacia Pharma in Cambridge, which is developing and commercialising hospital products for US and international markets, has won a key approval from the Food and Drug Administration.
The FDA has accepted for filing a New Drug Application (NDA) for BAREMSIS® (amisulpride injection, formerly APD421) for the management of post-operative nausea & vomiting (PONV). Under the Prescription Drug User Fee Act, the FDA has set a target date of October 5, 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 said: “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.”
• PHOTOGRAPH SHOWS: Dr Julian Gilbert