Acacia Pharma to change manufacturer of Barhemsys ingredient after FDA setback
Acacia Pharma has suffered a setback after the US Food and Drug Administration rejected its new drug application for a second time due to concerns over the contract manufacturing of an active ingredient.
The pharmaceutical company, based at the Officers’ Mess in Duxford, has developed Barhemsys, an amisulpride injection, to treat post-operative nausea and vomiting.
But a second complete response letter from the FDA highlights continuing deficiencies in the way the amisulpride in it is manufactured.
Acacia Pharma CEO Dr Julian Gilbert said: “We are extremely disappointed that the amisulpride manufacturer named in our application has still not been able to meet FDA’s required standards.
“As there were no other issues raised with our application, we remain confident that Barhemsys is approvable. 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 for Barhemsys.”
The letter comes days after Acacia Pharma presented positive phase III clinical trial data in a poster at the 2019 Annual Congress of Enhanced Recovery and Perioperative Medicine in Washington DC.
The double-blind study involving 702 adults compared single doses of Barhemsys against a placebo in patients with nausea or vomiting after surgery, who had previously received prophylactic antiemetics. It proved statistically significantly more effective than the placebo in preventing further vomiting or need for antiemetics.