Second CRL given to Acacia after ‘continuing deficiencies’
The US Food and Drug Administration (FDA) sent the company a complete response letter (CRL) after ‘continuing deficiencies’ were found at the unnamed contract manufacturer of the active pharmaceutical ingredient (API) of its drug candidate, Barhemsys (amisulpride injection).
Julian Gilbert, CEO of Acacia, said in a statement, that the company is ‘extremely disappointed’ that the amisulpride manufacturer in its application has still not been able to meet the FDA’s required standards.
Barhemsys is a treatment for post-operative nausea and vomiting. Acacia is focused on the development of anti-nausea and vomiting treatments for surgical and cancer patients. It has a further two product candidates that are based on the same API as Barhemsys in its pipeline.
According to Acacia, the FDA found no concerns with the clinical and non-clinical data submitted in the new drug application (NDA) and no further studies nor data analyses will be required for approval.
“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 the FDA as soon as possible to determine the most rapid route to obtaining approval for Barhemsys,” Gilbert added.
After its first CRL, Acacia remained committed to its API manufacturer stating that that contractor had been working collaboratively with the company to resolve the issue.