Acacia Pharma’s twice spurned drug finally makes the FDA cut

Third time’s the charm for Acacia Pharma.
The Cambridge, UK-based company on Thursday finally secured FDA approval for its treatment for patients with postoperative nausea & vomiting (PONV), who are symptomatic despite having received prophylactic treatment.
The drug, an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride, was shown to help patients in four positive pivotal clinical trials by 2017. But manufacturing troubles repeatedly hobbled the company’s quest to get the therapy — branded Barhemsys — on to the US market.
In late 2017, Acacia submitted an FDA application to market the drug — 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 — 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.
Julian Gilbert
With renewed enthusiasm later that month, Acacia’s 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 in May 2019, 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 at the time.
Now with the approval in tow, Acacia said it expects to launch the therapy in the second half of this year.
Acacia Pharma’s second product, remimazolam injection, is currently under review by the FDA for use in procedural sedation.

Acacia Pharma’s twice spurned drug finally makes the FDA cut