Acacia Pharma completes its post-approval requirement clinical trial testing Barhemsys in individuals with severe renal impairmentDecember 13, 2021
Acacia Pharma Group has completed 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.
“We are pleased to have completed this study in a timely fashion, despite the challenges associated with running clinical trials during the COVID-19 pandemic, and are delighted with the uniformly positive results,” said Gabriel Fox, Acacia Pharma’s Chief Medical Officer. “We plan to submit the data to FDA as soon as possible and believe the results will support amendment of the BARHEMSYS label to include use in patients with severe renal impairment. We also plan to publish the results of the study in a peer-reviewed journal during 2022. We extend our thanks to the 12 individuals who took part in the study and to the healthcare professionals who assisted in its conduct.”