Acacia Pharma Group has made final pivotal Phase 3 study testing amisulpride injection Baremsis, formerly APD421, for patients with post-operative nausea & vomiting (PONV), after getting antiemetic prophylaxis, and now all phases met primary endpoints.
Baremsis showed to be safe and efficient for the PONV suffering patients. Acacia Pharma’s CEO, Julian Gilbert, said that no other anti-emetic has a specific label for treating this unmet need
“We intend to position BAREMSIS as the drug of choice for treating the 30-40% of surgical patients who suffer PONV despite prior prophylaxis, as well as for combination prophylaxis in high-risk patients,” said Gilbert.
Next step for Acacia is submitting to the US FDA its New Drug Application (NDA) in first six months of 2017. The company will seek the approval for Baremsis for the said effect, alone and in combination.