Acacia Pharma seeks clarification from FDA over knockback
Acacia Pharma is seeking urgent clarification from the US Food and Drug Administration which identified deficiencies at an inspection of the contract manufacturer of an ingredient used in the Cambridge company’s BARHEMSYS™ – post-operative nausea & vomiting (PONV) solution.
BARHEMSYS is an intravenous formulation of amisulpride, a selective dopamine antagonist, which has completed Phase 3 clinical development for the prophylaxis and treatment of PONV, alone and in combination with other antiemetics.
Acacia, which is developing and commercialising hospital products for US and international markets, received a Complete Response Letter from the FDA concerning its New Drug Application for BARHEMSYS (an amisulpride injection).
The letter identified that deficiencies had been reported during a recent pre-approval FDA inspection of the contract manufacturer. Acacia says no inadequacies were noted regarding the purity or stability of the active ingredient, or the manufacturing process or quality of the finished product.
It adds that no concerns were raised by the FDA on any of the clinical or non-clinical data in the application and no further studies or data analyses will be required for approval.
Acacia CEO Dr Julian Gilbert (pictured) said: “We are surprised to have received this Complete Response Letter, which relates solely to issues at the facility of our contract drug substance manufacturer.
“We intend to seek urgent clarification from FDA and the contract manufacturer as to the status and procedure for resolution of the deficiencies that have been identified. We believe that such resolution could occur quickly and we continue to prepare for an anticipated launch in the first half of 2019.”