FDA sets PDUFA target date for Barhemsys

The US Food and Drug Administration (FDA) has accepted UK-based Acacia Pharma (Euronext: ACPH) resubmitted New Drug Application (NDA) for Barhemsys (amisulpride injection). The FDA has classified the resubmission as Class 2 and has given a Prescription Drug User Fee Act (PDUFA) goal of reviewing and acting on it no later than February 26, 2020.

This is a welcome development for Acacia, which had previously received two complete response letters from the FDA, as the agency identified continuing deficiencies at the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in Barhemsys, a candidate for post-operative nausea and vomiting.

The news also caused a rise in Acacia’s shares (which had been battered by news of the CRLs) by 2.08% to 1,87 euros.