Acacia Pharma Group plc announces that data and analyses from its positive Phase 3 clinical trial of BARHEMSYS™ (intravenous amisulpride) as rescue treatment of established post-operative nausea & vomiting (PONV) have been published (Habib et al1) in the online edition of the leading peer-reviewed journal Anesthesiology. Positive headline results were first announced by the company in February 2017.
Dr Ashraf Habib, Professor of Anesthesiology at Duke University School of Medicine and chief investigator of the study, said: “The key unmet need in PONV is the rescue of patients who develop nausea or vomiting, despite having received the current standard-of-care antiemetic prophylaxis. The results from this published Phase 3 trial are very encouraging as they showed that BARHEMSYS was effective at rescuing patients who had failed prophylaxis, without causing sedation. If approved, BARHEMSYS would offer physicians and patients a new option for the rescue treatment of PONV.”
A New Drug Application (NDA) for BARHEMSYS, including data from this and three other positive Phase 3 trials, is under review by the US Food and Drug Administration (FDA). The extensive clinical trial programme has studied the safety and efficacy of BARHEMSYS for investigational new uses in the treatment of established PONV, whether or not prior prophylaxis was given, and the prevention of PONV, alone or in combination with other antiemetics.
Dr Gabriel Fox, Acacia Pharma’s Chief Medical Officer, added: “About one-third of surgical patients who receive prophylactic antiemetics prior to surgery still go on to suffer from PONV and this represents an important challenge for the surgical team. This is especially the case as no other antiemetic has been shown in a prospective trial to be effective in that setting. If BARHEMSYS is approved by FDA for this indication, we believe it will become a valuable part of the antiemetic armamentarium and an important option for patients and physicians in the US.”
Reference: Habib, A.S. et al. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis – A Randomized, Placebo-controlled Phase III Trial. Anesthesiology 2018, doi:10.1097/ALN.0000000000002509
Acacia Pharma is based in Cambridge, UK and its US operations are centred in Indianapolis, IN. www.acaciapharma.com