SkyePharma announces Flutiform study results

SkyePharma has announced the results of the third phase III Flutiform efficacy study, with the compound meeting its primary endpoints and completing its original core clinical trial programme.

The compound is being assessed as a treatment for mild-to-moderate asthma in adolescent and adult patients, with a number of studies being conducted ahead of a regulatory filing for the drug.

In a top-line key results analysis, Flutiform showed statistically significant improvements in forced expiratory volume in the first second – the primary endpoint of the study – compared with the administration of formoterol or fluticasone taken alone.

Furthermore, the number of patient discontinuations as a result of lack of efficacy was lower for Flutiform compared to placebo.

Ken Cunningham, chief operating officer and chief executive officer-designate of SkyePharma, said: “We are very pleased with the progress being made with the development of Flutiform and now look forward to the results of the one remaining clinical efficacy trial required for the US filing.”

He added that this study is being conducted by Abbot subsidiary Kos Life Sciences and is due to be completed in the second half of the year.

Last month, SkyePharma announced a major step forward in the development of Flutiform with the publication of the preliminary results of the Sky2028-4-004 study of the compound.