ERS 2014: Mundipharma reports positive Ph III results for flutiform in pediatric asthma

UK inhalation drug delivery specialist Skyepharma (LSE SKP) today announced that new data from a randomized, multicenter, pivotal Phase III study of flutiform for the treatment of pediatric asthma has been presented at the European Respiratory Society (ERS) annual congress in Munich, Germany, by its licensing partner.

Privately-held Swiss drugmaker Mundipharma said that the data show the efficacy and tolerability of flutiform, a combination of fluticasone propionate and formoterol in a single pressurised metered dose inhaler,in children with asthma aged five to <12.

The primary endpoint of this 12-week study was the change from pre-dose FEV1 (forced expiratory volume in one second, a key measure of lung capacity) at baseline to 2-hour post-dose FEV1at the end of the study period. Flutiform (50/5mcg 2 puffs twice per day) was superior to fluticasone propionate (50mcg 2 puffs twice per day) and non-inferior compared with the commonly used combination fluticasone propionate/salmeterol (50/25mcg 2 puffs twice per day) for the primary endpoint. The study also showed flutiform had a similar tolerability profile to fluticasone propionate and fluticasone propionate/salmeterol.