Acacia seeks new manufacturer following fresh Barhemsys CRL

UK-based Acacia Pharma (Euronext: ACPH) appears to have made a costly error with its choice of contract manufacturer for Barhemsys (amisulpride injection), a candidate for post-operative nausea and vomiting.

Barhemsys has generated positive results in four Phase III clinical studies but Acacia has now received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) in relation to its New Drug Application (NDA).

As with the first CRL that Acacia received for Barhemsys in October 2018, the FDA has again said that there is nothing wrong with any of the clinical or non-clinical data in the NDA and that no further studies or data analyses will be required for approval.