Acacia, twice foiled by manufacturing CRLs, gets 2020 PDUFA after bringing on new API maker

Biotech Acacia, which has two drug candidates based on the API amisulpride, hopes to get one of those approved in February 2020 after a long approval journey which has been extended by manufacturing issues at its initial API supplier. (Pixabay)

Will three be the charm for biotech Acacia and its drug candidate for postoperative nausea and vomiting? With a new contract manufacturer on board following two manufacturing-related denials by the FDA, the drugmaker said it has won its third action date, which is set for early in 2020.

The drugmaker last week announced the FDA has set February 26 as its new PDUFA date for a decision on Barhemsys, its injected PONV drug. It said the goal was set after the company nominated an alternative contract manufacturer to supply the API amisulpride for Barhemsys. It sad the CDMO has successfully passed regular inspections by the FDA. 

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“Our team has worked very hard qualifying a new supplier of amisulpride for our application and I am delighted how quickly this has been achieved. Given the proven track record of our new supplier, we are very confident of success in this review period and our commercial team is well-positioned to launch Barhemsys in the USA next year,” Acacia Pharma CEO Mike Bolinder said in a statement.

Bolinder became CEO in July after Acacia founder Julian Gilbert stepped down in what the company referred to as a planned succession. 

While amisulpride, the API in Acacia’s drug candidate, has been used for years to treat schizophrenia, the FDA in May hit the company with its second CRL tied to its unidentified contractor’s inability to resolve issues the FDA wanted fixed. The company, which has operations in Cambridge, UK and Indianapolis, Indiana, received its first CRL in 2018. It has a second drug candidate using amisulpride that it also is developing.