Acacia re-submits application to FDA
Cambridge life science company Acacia Pharma believes it is back on track to launch a novel treatment for post operative nausea and vomiting in the US in the first half of 2019.
The FDA put the brake on progress when it identified deficiencies at the contract facility employed to manufacture Acacia’s BARHEMSYS™ (amisulpride injection).
Acacia and the contract facility have worked overtime to address the deficiencies identified and the company has now re-submitted its New Drug Application to the FDA. A decision is expected in the near future and Acacia is planning for the best case scenario.
CEO Julian Gilbert said: “Our contract manufacturer has worked diligently to institute a corrective and preventative action plan that we are confident will rectify the deficiency identified by the FDA. We continue to plan for a launch in the first half of 2019.”
Acacia also issued a trading update for the nine months to September 30 showing it ended the period with cash of £33.8 million – slightly ahead of expectations at the time of the company’s IPO in March 2018.
It made a slightly higher but still small loss despite increased expenditure on research and product development ahead of next year’s major commercial push in the States.