BRIEF—FDA given further nudge on Barhemsys ahead of action date

Acacia Pharma has added to the positive data on Barhemsys (intravenous amisulpride) as a rescue treatment in established post-operative nausea & vomiting.

The company has presented additional data and analyses from the Phase III trial, which met its primary endpoint through Barhemsys leading to no recurrence of vomiting or requirement for further antiemetic rescue for the 24-hour period after rescue treatment.

Barhemsys has proven itself to be more effective than placebo according to the data, giving Acacia confidence in its re-submitted New Drug Application (NDA), which includes data from this and three other positive Phase III trials. The NDA is under review by the US Food and Drug Administration, with a target action date of May 5.