FDA rejects Acacia's lead drug — again — due to the same manufacturing issue
Acacia Pharma did well on the R&D front — by 2017, it had conducted four positive pivotal clinical trials for its lead drug, Barhemsys. Later that year, it submitted an FDA application to market the drug for rescue treatment of patients who develop postoperative nausea & vomiting (PONV), despite having been given prior antiemetic prophylaxis — only to receive a rejection in October 2018.
The US agency made its decision based on a pre-approval inspection of a facility run by the contract manufacturer of the drug’s main ingredient — amisulpride — and not on clinical or non-clinical data in the application, assured Acacia in a press release, adding that the FDA had asked for no extra studies or data analyses related to the treatment.
With renewed enthusiasm later that month, Acacia said its contract manufacturer had agreed to “institute a corrective and preventive action plan that will rectify the deficiency identified as quickly as possible. We continue to plan for a launch in the first half of 2019,” Acacia chief Julian Gilbert said in a statement.
Acacia then resubmitted its marketing application in December, indicating that the FDA’s concerns outlined in the complete response letter had been resolved. But on Friday, the company received another rejection, with the FDA flagging the same concerns.
“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,” Gilbert said in a statement on Friday.
Barhemsys is designed to help the 30-40% of surgical patients who suffer from PONV despite prior prophylaxis, as well as for combination prophylaxis in high-risk patients.
Cambridge, UK-based Acacia Pharma, which also has US operations in Indianapolis, was founded in 2007. It has another amisulpride-based drug — APD403 — in mid-stage development for chemotherapy induced nausea & vomiting.