SkyePharma’s run of good news continues apace as the UK drug delivery firm has announced that a late-stage study of its flagship asthma combination drug Flutiform has proved successful.

The company said that a Phase III efficacy study evaluating Flutiform (fluticasone and formoterol) for the treatment of asthma in adolescent and adult patients, the first of several being carried out in preparation for regulatory filing, met its primary endpoints. The 357-patient study compared Flutiform versus fluticasone (100ug twice daily) and formoterol (10ug twice daily) and showed that the levels of improvement in FEV1 (forced expiratory volume in the 1st second showed statistically significant differences in favour of SkyePharma’s product compared with both fluticasone and formoterol taken alone.

Chief executive Frank Condella said the preliminary results of the study “represent a key step forward in the development of Flutiform”. He added that the results, together with the late-stage safety trial reported last year, will form part of a New Drug Application in the USA which is expected to be filed in the first quarter of 2009. That filing is reliant on an additional efficacy study, which has commenced recruitment and if approved, Flutiform will be distributed by Abbott Laboratories.

The news comes a week after the signing of a licensing deal with Japan’s Kyorin Pharmaceutical Co for Flutiform and a fortnight since European marketing partner Mundipharma successfully completed a paediatric study with positive results on the combination drug.