BARHEMSYS™ (formerly APD421) is an intravenous formulation of amisulpride, a selective dopamine antagonist, which has completed Phase 3 clinical development for the prophylaxis and treatment of PONV, alone and in combination with other antiemetics. A New Drug Application (NDA) seeking marketing approval for BARHEMSYS™ in these indications has been accepted for review by the FDA. Under the Prescription Drug User Fee Act (PDUFA), FDA has set a target date of 5 May 2019 to complete its review.
Four pivotal Phase 3 clinical trials investigating BARHEMSYS™ for the management of PONV have been successfully completed. Two investigated the treatment of established PONV (one in patients who had received prior prophylaxis with standard antiemetics, and one in patients who had not received any prophylaxis) and two investigated the prophylaxis (prevention) of PONV alone, or in combination with standard antiemetics.