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news.SkyePharma has filed a new drug application for Flutiform, the company's lead development product for the maintenance treatment of asthma in patients 12 years of age and older, with the FDA.
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Primary endpoints were met in all of the clinical programs required for the submission of the new drug application (NDA), comprising a long-term safety study and four efficacy studies, covering nearly 2,300 patients, said SkyePharma.
Flutiform HFA-MDI is a fixed-dose combination of an inhaled corticosteroid fluticasone and formoterol, long-acting beta agonist in a metered dose inhaler.
Ken Cunningham, CEO of SkyePharma, said: “The submission of the NDA
for Flutiform is a major milestone for SkyePharma. We believe that Flutiform, when approved, will provide physicians and asthma patients with an additional treatment option to better manage this serious, chronic condition.”