Flutiform fluticasone/formoterol: Phase III data

Top-line data from the double-blind, Hungarian Phase III FLT-3503 trial showed that the high dose of Flutiform (500µg fluticasone/20 µg formoterol) met the co-primary endpoints of non-inferiority to 500 µg Flixotide fluticasone plus 24 µg Foradil formoterol in improved mean FEV1 from baseline to pre-dose FEV1 and 2-hour post-dose FEV1 at 8 weeks in the per protocol (PP) population of 529 adults with severe, persistent and reversible asthma. SkyePharma said the data will enable an MAA submission in 1Q10 as planned. The trial also enrolled two arms that received low-dose Flutiform (100 µg fluticasone/10 µg formoterol) or 500 µg Flixotide alone. Flutiform was well tolerated. ...