According to Discovery Laboratories its Aerosurf aerosolized surfactant development program “currently remains on track for the Phase 2 clinical program in the fourth quarter of 2013” and is unaffected by the FDA’s recent questions about product specifications for Discovery Labs’ Surfaxin intratracheal suspension surfactant. The company says that it will respond to the FDA within the next two months and still plans to launch Surfaxin in the fourth quarter of this year.
After determining last year that an analytical test being used to assess Surfaxin “required improvement,” Discovery Labs updated specifications for the product. The company says that “The current improvement and validation of the analytical chemistry method used to assess specification conformance for Surfaxin drug product has no technical impact on the Aerosurf program.”
In February 2013, Discovery Labs obtained $30 million in financing for development of Aerosurf and Surfaxin.
Read the Discovery Labs press release.
