SkyePharma PLC announces that the final US phase-III efficacy study evaluating Flutiform for the treatment of moderate to severe asthma in adolescent and adult patients has met its primary endpoint. The study is the last phase-III clinical efficacy study to be carried out in preparation for regulatory filing.

In a top line analysis of key results, the levels of improvement in FEV1 (forced expiratory volume in the first second), the primary endpoint in the active treatment arms, showed statistically significant differences in favour of Flutiform compared with two different formulations of fluticasone taken alone.

The study (SKY2028-3-005) was conducted in centres across the United States, Latin America and Europe; and the full data set includes a total of 438 patients. The study was a randomised, double-blind, active-controlled, parallel group, stratified, multi-centre, 12-week study comparing the safety and efficacy of fluticasone and formoterol combination (Flutiform 250/10?g twice daily) in a single inhaler (SkyePharma HFA pMDI) with the administration of fluticasone (250?g twice daily) alone in two different formulations in adolescent and adult patients with moderate to severe asthma. Patients were treated for 12 weeks after initial screening and a two week run-in period.

Dr Ken Cunningham, CEO of SkyePharma, said, "This final successful phase-III efficacy study is the last trial to be completed prior to the submission of the NDA which is on track for filing with the FDA in Q1 2009."

Using its proprietary drug delivery technologies, SkyePharma develops new formulations of existing products to provide a clinical advantage and life-cycle extension.

Flutiform HFA-MDI is a fixed-dose combination of formoterol and fluticasone in a metered dose inhaler (MDI).