Acton Pharmaceuticals has published positive results from a Phase 3b clinical trial of its Aerospan flunisolide HFA metered dose inhaler in the October issue of Annals of Allergy, Asthma & Immunology. The article, titled, “Linear growth and bone maturation are unaffected by 1 year of therapy with inhaled hydrofluoroalkane in prepubescent children with mild persistent asthma: A randomized, double blind, placebo-controlled trial” describes a study involving 218 children. Aerospan is an inhaled corticosteroid licensed by Acton from Forest Laboratories in 2009 and is Acton’s only product.
Acton Executive VP and Chief Medical Officer Kenneth Newman commented, “Results from this trial will provide important information to physicians, particularly those who treat children with asthma. It is not known whether these results would continue beyond one year and it is important for physicians to be alert for and to monitor growth in children due to the labeling precautions associated with inhaled steroids, including Aerospan.”
In early 2010, the company planned to launch the Aerospan HFA MDI in 2011; now it says that it “plans to commercialize Aerospan upon completion of certain manufacturing requirements.” The FDA originally approved Aerospan in 2006; Acton filed a manufacturing supplement to the NDA in November 2010 and said at the time that it was aiming for a mid-2011 launch.
Read the Acton Pharmaceuticals press release.
