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news.SkyePharma has announced that its second Phase III efficacy study evaluating FlutiformTM for the treatment of moderate to severe asthma in adolescent and adult patients has met its primary endpoints.
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The study was conducted in centres across the US and Europe. The full analysis set includes a total of 557 patients. The study was a randomized, double-blind, placebo-controlled, parallel group, stratified, multi-centre study comparing the safety and efficacy of fluticasone and formoterol combination in a single inhaler versus the administration of either placebo or fluticasone or formoterol alone in adolescent and adult patients with moderate to severe asthma. Patients were treated for 12 weeks after initial screening and a 14 day run-in period.
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 FlutiformTM compared with both fluticasone and formoterol taken alone. In addition, the results demonstrated a significantly lower number of discontinuations due to lack of efficacy for FlutiformTM as compared with placebo.
The results of this second study, together with the long-term Phase III safety trial reported in 2007 and the first efficacy trial, will form part of the new drug application (NDA) for US approval for FlutiformTM. According to the company, recruitment is ongoing for the additional efficacy study required for the NDA and the overall development program remains on schedule for the NDA to be filed in the first quarter of 2009.