The green light from the U.S. Food and Drug Administration marks the first approval for U.K.-based Acacia.
Shares of Acacia Pharma have skyrocketed more than 18% in early trading after the company announced it had finally secured approval for Barhemsys (amisulpride injection) for the prevention and treatment of postoperative nausea and vomiting (PONV) in adults.
The green light from the U.S. Food and Drug Administration (FDA) marks the first approval for U.K.-based Acacia. And, it hasn’t been an easy road for the company. Two years ago, the FDA issued a Complete Response Letter to the company regarding found deficiencies at the contract manufacturing company that Acacia was using to source amisulpride, the active pharmaceutical ingredient in its medication. After finding a new supplier of amisulpride, Acacia resubmitted its New Drug Application last year.
Mike Bolinder, chief executive officer of Acacia, said the FDA approval of Barhemsys marks a significant milestone in the evolution of the company. The approval has moved Acacia into an integrated hospital pharmaceutical company with strong development and commercialization capabilities, Bolinder said. He said the goal is for Barhemsys to become the new standard of care in the United States for the treatment of PONV in patients who have failed standard prophylaxis, the area of highest unmet need.
“The results of our extensive clinical program also allow us to offer Barhemsys 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,” Bolinder said in a statement.
Barhemsys is an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride. The approval was supported by data from four positive Phase III studies. The approval for Barhemsys covers the treatment of PONV in patients who have 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. In a study involving patients who had failed the most commonly used antiemetic prophylaxis, a single 10 mg dose of Barhemsys was significantly more effective than placebo at treating patients, 42% vs 29%, Acacia said. In a study in patients at the highest risk of suffering from PONV, a single 5 mg dose of BARHEMSYS in combination with another antiemetic significantly improved protection from PONV compared to placebo plus another antiemetic, 58% vs 47%, Acacia added.
Acacia intends to launch Barhemsys in the United States in the second half of this year.
Acacia could see a second product approved by the FDA later this year. The regulatory agency is reviewing Byfavo (remimazolam injection) for use in procedural sedation in adults. A PPDUFA date of April 5 has been set by the FDA.
