SkyePharma shows Flutiform not inferior

SkyePharma says that its partner, privately-held Swiss drugmaker Mundipharma, has successfully completed two Phase III studies in the European development program for Flutiform (fluticasone/formoterol), both of which show positive results.

The two randomized, open-label, parallel-group studies, FLT-3501 and FLT-3505, assessed over 300 patients, suffering from mild to moderate-severe, persistent and reversible asthma over 12 weeks of treatment. The trials compared Flutiform to Seretide (fluticasone) and to Flutiform's individual components, fluticasone and formoterol, respectively, with the goal of demonstrating comparable efficacy between treatment arms. Mean pre-dose forced expiratory volume in the first second was the primary endpoint and the top-line analysis shows the performance of Flutiform was not statistically inferior, according to the company.

SkyePharma's chief operating officer, Ken Cunningham, said he was "delighted that, along with the three Phase III pivotal efficacy studies conducted for New Drug Applications submission, we now have two further Phase III studies for European regulatory submission that have met their primary endpoints."