Acacia Pharma secures first FDA approval with Barhemsys for postoperative nausea and vomiting

UK-based Acacia Pharma has secured its first US approval with the FDA’s decision to authorise Barhemsys (amisulpride injection) for the prevention and treatment of postoperative nausea and vomiting (PONV).

The approval specifically relates to adult patients who have previously received antiemetic prophylaxis “with an agent of a different class or who have not received prophylaxis and the prevention of PONV, either alone or in combination with an antiemetic of a different class”.

The approval was based on data derived from four Phase 3 comprising 3,300 participants, demonstrating that the therapy was “significantly more effective” at treating the condition in patients compared to placebo.

Barhemsys confirmed it intends to market the product directly in the US market in the second half of this year.

“The approval of our first product represents a significant milestone in Acacia Pharma’s evolution into an integrated hospital pharmaceutical company with strong development and commercialisation capabilities,” commented Mike Bolinder, CEO at Acacia Pharma. “Our goal is for Barhemsys to become established as the new standard of care in the US for the treatment of PONV in patients who have failed standard prophylaxis, the area of highest unmet need. The results of our extensive clinical programme also allow us to offer Bsrhemsys as an option for the prevention of PONV in higher-risk patients and settings, where combination prophylaxis can be valuable. We are on target with our commercial preparations and expect to launch Barhemsys in the second half of this year.”

Matt Fellows