Acacia gets 2nd FDA rejection as manufacturing fault drags on

Acacia Pharma has suffered its second FDA rejection in seven months. The British drug developer moved quickly to bounce back from the complete response letter (CRL) it received in October, only to be hit with a second rejection after its contract manufacturer failed to resolve the problems.
After disclosing the first CRL for post-operative nausea and vomiting drug Barhemsys last year, Acacia continued to prepare to introduce the drug in the first half of 2019 in the belief the problems behind the rejection would be quick to resolve. Acacia told investors the issue was limited to one regulatory compliance deficiency at the third party that produces the active ingredient in Barhemsys, and that the FDA had no qualms with the quality of the drug or the R&D data included in the submission. Within one month of the CRL, the contract manufacturer submitted a plan to fix the problem and Acacia refiled for FDA approval of Barhemsys. Shares in Acacia rose sharply in March and April in anticipation of the May 5 PDUFA decision.