SkyePharma Gets Good News in Phase III Efficacy Study

SkyePharma met its primary endpoint for its third Phase III trial evaluating Flutiform for the treatment of mild-to-moderate asthma in adolescent and adult patients.

Flutiform is a fixed-dose combination of formoterol and fluticasone in a metered dose inhaler. The randomized, double-blind, placebo-controlled, parallel-group, stratified, multicenter trial studied 475 patients over 12 weeks. The safety and efficacy of the drug were compared with placebo or fluticasone or formoterol alone.

Compared with placebo, the Flutiform group showed improvement in breathing and had fewer discontinuations, the company said.