Acacia to file NDA for PONV drug within months

Acacia Pharma has announced positive results from its fourth and final pivotal Phase III study investigating Baremsis (amisulpride injection) for the rescue treatment of patients who develop post-operative nausea and vomiting (PONV), despite having received prior anti-emetic prophylaxis.

The UK-based company, which is developing supportive care product opportunities for post-surgical and cancer patients, now plans to submit a New Drug Application (NDA) to the US Food and Drug Administration in the first half of this year.

Julian Gilbert, Acacia Pharma’s chief executive, said: “We are delighted with these results demonstrating that Baremsis is safe and effective at rescuing patients who suffer PONV despite having received prior prophylaxis with standard anti-emetics.