Acton Pharmaceuticals announced that the FDA has approved the sNDA (Supplemental New Drug Application) for Aerospan (flunisolide HFA, 80mcg) inhalation aerosol, indicated for the maintenance treatment of asthma as a prophylactic therapy in adult and pediatric patients >6 years old.
Aerospan, an orally inhaled corticosteroid, was evaluated in a double-blind, parallel, placebo- and active-controlled study of 669 patients aged 12–78 previously treated with inhaled corticosteroids. Both approved doses, 160mcg and 320mcg, were significantly superior to placebo in the primary endpoint of FEV1 (the amount of air forcefully exhaled in one second). Aerospan was developed with an integrated spacer device.
Aerospan inhalation aerosol is set to launch in early 2013.
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