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BARHEMSYS® – Postoperative nausea & vomiting (PONV)

BARHEMSYS® (formerly APD421) is an intravenous formulation of amisulpride, a selective dopamine antagonist. It is approved in the US for treatment and prophylaxis of PONV, alone and in combination with other antiemetics (February 2020) and US launch is planned for 2H 2020.

Approval was gained on the positive results of four pivotal Phase 3 clinical trials investigating BARHEMSYS® for the management of PONV. 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.

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