- Acacia Pharma's path forward for its experimental drug Barhemsys looks a little clearer, after the Cambridge, U.K.-based company disclosed Monday it anticipates soon being able to resubmit a New Drug Application to the Food and Drug Administration.
- Acacia's hopes for Barhemsys were dashed earlier this month when the FDA issued a Complete Response Letter for the drug, which is in development for the prevention and treatment of post-operative nausea and vomiting.
- The CRL raised issues related to an inspection of the contract manufacturing facility where Barhemsys' active ingredient, amisulpride, is sourced from. Regulators raised no concerns about the purity or stability of the active ingredient, nor the quality of the finished product, however. Acacia continues to prepare for an anticipated launch in the first half of 2019.
The CRL was an unexpected hurdle for Acacia.
When the company disclosed its receipt, CEO Julian Gilbert noted Acacia's surprise at the letter, which resulted from issues with the contracted drug substance manufacturer.
At the beginning of October, Acacia Pharma's contract manufacturer told the company it had received a post-inspection notification from FDA, and that the facility complied with current good manufacturing practices.
Yet a few days later, regulators sent the unnamed contract manufacturer a copy of an "untitled letter" — a request to correct issues not significant enough to merit a warning letter — that included details of a single deficiency which need to be corrected before Barhemsys (amisulpride injection) could be approved.
"Our discussions with FDA and our contract manufacturer over the past week have been productive," said Gilbert in Monday's update. "Our contract manufacturer is fully committed to working with Acacia Pharma to institute a corrective and preventative action plan that will rectify the deficiency identified as quickly as possible."
That plan will be completed within one month, Acacia said, at which point the company could then resubmit.
While Acacia sees a path to market by early next year, its struggles demonstrate how a single manufacturing issue can derail an application — something even large drugmakers can run into, too.
Acacia's shares, which are traded on the Brussels stock exchange, have taken a hit since the CRL was disclosed.