Acacia Pharma has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Barhemsys (amisulpride injection).
The letter marks the second for this particular submission, and identified continuing deficiencies at the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in Barhemsys.
The same issue was raised initially in October 2018 when the company received their first Complete Response Letter from the FDA.
Despite the rejection, no concerns were raised by the FDA on any of the clinical or non-clinical data in the NDA and no further studies or data analyses will be required for approval.
The company are “extremely disappointed that the amisulpride manufacturer named in our application has still not been able to meet FDA’s required standards,” said Dr Julian Gilbert, chief executive of Acacia Pharma.
“As there were no other issues raised with our application, we remain confident that Barhemsys is approvable. We are on track to complete the qualification of an alternative supplier of amisulpride and plan to engage with FDA as soon as possible to determine the most rapid route to obtaining approval for Barhemsys.”
The submission includes data from four Phase III trials, including positive results from a study evaluating Barhemsys as a rescue treatment for patients who received prior antiemetic prophylaxis.
The drug is a novel dopamine D2/D3 antagonist being evaluated for the management of post-operative nausea and vomiting.