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Acacia Pharma Says MAA For BARHEMSYS Under Formal Review In Major European Markets

Acacia Pharma Group plc, a commercial stage biopharmaceutical company, announced Wednesday that its marketing authorization application or MAA for BARHEMSYS (amisulpride injection) has been submitted, validated and is now under formal review in major European markets.

The review process is expected to be completed by the third quarter of fiscal 2022.

BARHEMSYS is a selective dopamine-2 or D2 and dopamine-3 or D3 receptor antagonist, which Acacia Pharma has developed and protected for the management of postoperative nausea & vomiting or PONV.

BARHEMSYS was approved in February 2020 by the Food and Drug Administration for use in the United States to prevent and treat postoperative nausea & vomiting or PONV. It became commercially available in August 2020.

The MAA submission includes data from four positive Phase 3 studies investigating BARHEMSYS. This includes the first ever randomized, controlled trial to show successful treatment of active PONV in patients who have failed prior prophylaxis.

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