Acacia Pharma Group plc announced the successful completion of its post-approval requirement clinical trial investigating the effects of BARHEMSYS® (amisulpride injection) in individuals with severe renal impairment. The study showed no clinically relevant difference in the pharmacokinetics, electrocardiogram (ECG) parameters or safety profile of BARHEMSYS between individuals with or without severe renal impairment. No adverse events were recorded in any subject. The clinical trial was required by the US Food and Drug Administration (FDA) as part of the February 2020 approval of BARHEMSYS for the prevention and treatment of postoperative nausea and vomiting (PONV). It was conducted at a specialist Phase 1 unit in Florida and enrolled six subjects with severe renal impairment (defined as an estimated glomerular filtration rate below 30 mL/min/1.73 m2) and six matched healthy volunteers. Participants received a single 10 mg intravenous dose of BARHEMSYS, followed 24 hours later by a single 10 mg oral dose of the active ingredient, amisulpride.