Phase III study of Barhemsys as rescue treatment of post-operative nausea & vomiting (PONV) has been published in Anesthesiology.- Acacia Pharma

Acacia Pharma Group plc announced that data and analyses from its positive Phase III 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, the official publication of the American Society of Anesthesiologists.

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 III 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.�

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.

See- 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 [epub ahead of print].

Comment: Acacia received a Complete Response Letter from the FDA regarding its New Drug Application (NDA) for Barhemsys (amisulpride injection). The letter identified that deficiencies had been reported during a recent pre-approval FDA inspection of the contract manufacturer of amisulpride.