It took three attempts, but Acacia Pharma has now won FDA approval of Barhemsys, its treatment for postoperative nausea and vomiting. The agency seal of approval comes after it twice rebuffed the drug candidate over manufacturing concerns with Acacia’s production partner, which Acacia says has now been approved to make its API.
The company announced today the FDA approved Barhemsys, an intravenous formulation of amisulpride, for treating postoperative nausea and vomiting in patients that didn’t respond to treatment with an antiemetic from a different class.
“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 commercialization capabilities,” Acacia Pharma CEO Mike Bolinder said in a statement. "We are on target with our commercial preparations and expect to launch Barhemsys in the second half of this year.”
In an email, the company said that the initial CDMO has now been approved.
Acacia, which is specializing in hospital targeted treatments, got its first complete response letter in 2018 when the FDA found fault with Acacia's manufacturer during a preapproval inspection. Acacia resubmitted its application within the month saying its CDMO had put together a corrective and preventive action plan that should resolve the concerns.
In May 2019, the FDA said the contractor had not resolved the problems and again sidelined Acacia’s candidate. At that point, the Cambridge, U.K.- and Indianapolis-based biotech moved to get a new contractor certified for the API and then late last year said it was ready to take another shot. It never identified either CDMO.
Acacia today said its commercial plans are in place, and it intends to launch Barhemsys in the second half of the year.