The US Food and Drug Administration (FDA) issued Acacia Pharma a complete response letter (CRL) in response to its new drug application (NDA) for Barhemsys (amisulpride injection) on October 5.
The candidate is an intravenous formulation of a selective dopamine antagonist, amisulpride, administered for the prophylaxis and treatment of post-operative nausea and vomiting (PONV).
In the CRL, the FDA flagged a manufacturing deficiency reported during a recent pre-approval inspection of a contractor’s facility. The unnamed company is responsible for the manufacture of amisulpride – the active ingredient in Barhemsys.
Acacia Pharma did not disclose specifics but confirmed that “no inadequacies were noted regarding the purity or stability of the active ingredient, or the manufacturing process or quality of the finished product.
“Furthermore, no concerns were raised by FDA on any of the clinical or non-clinical data in the application and no further studies or data analyses will be required for approval.”
CEO Julian Gilbert told us the firm remains committed to its API manufacturer, and together, with the help of a contracted ex-FDA official, are putting together a corrective and prevention action plan for US regulators.
“They [the contractor] have been the supplier of the raw material for a significant period of time and are working collaboratively with us to resolve the issue that we believe is eminently resolvable, and therefore we think that is the most expeditious way for us to get our NDA approved,” said Gilbert.
“Based on our view of the information that we have available to us, we are going to continue to plan for a launch in the first half of 2019,” he added.