Florida key to Acacia Pharma FDA application
Cambridge biopharma business Acacia has taken another major step forward in its bid for FDA backing for a treatment for severe renal impairment.
No adverse events were recorded in the clinical trial, which was conducted at a specialist Phase 1 unit in Florida.
The trial was required by the FDA as part of a February 2020 approval of BARHEMSYS for the prevention and treatment of postoperative nausea and vomiting (PONV).
The study showed no clinically relevant difference in the pharmacokinetics, electrocardiogram parameters or safety profile of BARHEMSYS between individuals with or without severe renal impairment.
Dr Gabriel Fox, Acacia Pharma’s chief medical officer, said: “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.
“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.”