Acacia receives CRL on Barhemsys

8 October 2018

UK-based Acacia Pharma (Euronext: ACPH) plunged on news of a delay in US approval for its treatment and prophylaxis of post-operative nausea and vomiting (PONV) drug candidate.

Acacia has received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its New Drug Application (NDA) for Barhemsys (amisulpride injection), with the news pushing the stock down 23.38% to 3.03 euros by late morning trading.

The letter identified that deficiencies had been reported during a recent pre-approval FDA inspection of the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in Barhemsys. No inadequacies were noted regarding the purity or stability of the active ingredient, or the manufacturing process or quality of the finished product.

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