Flutiform meets Ph III efficacy endpoint

UK drugmaker SkyePharma has reported strong late-stage efficacy on the asthma product Flutiform (a formoterol and fluticasone combination in a metered-dose inhaler), its lead development product. The Phase III trial, which assessed the agent in adolescent and adult patients and is the first of several being conducted in preparation for regulatory filing, met its primary endpoints.

The 357-patient, randomized, double-blind, active-controlled, parallel-group, 12-week study comparing the safety and efficacy of a fluticasone and formoterol combination (Flutiform 100/10ug twice daily) in a single inhaler versus the administration of fluticasone (100ug twice daily) and formoterol (10ug twice daily) alone in mild-to-moderate asthma patients.

In a top line analysis of key results, the levels of improvement in forced expiratory volume in the first second, the primary endpoints measured, showed statistically-significant differences in favor of Flutiform compared with both fluticasone and formoterol taken alone. Top-line results from the remaining Phase III trials will be announced in the coming months. Last year, shares in SkyePharma fell 16% after the US New Drug Application for Flutiform was delayed by a need for more data. The additional efficacy study has commenced recruitment and the overall development program remains on schedule for the NDA to be filed in first-quarter 2009, the firm noted.