Strong Ph III data on SkyePharma's Flutiform
UK drug developer SkyePharma presented a Phase III, long-term, open-label safety study evaluating Flutiform (a formoterol and fluticasone combination in a metered-dose inhaler), its lead development product, for the treatment of asthma in adolescent and adult patients at the American Thoracic Society meeting, in Toronto, Canada.
The study involved 472 patients, who were assigned to treatment with Flutiform, either 100mg/10mg or 250mg/10mg twice daily, for six or 12 months. The results of this trial will form part of the US New Drug Application for Flutiform. As announced on April 30, a top line analysis of key results of the first Phase III efficacy study demonstrated statistically-significant differences in favor of
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