The UK’s Skyepharma says that partner Mundipharma has commenced an international clinical trial of the firms’ asthma drug Flutiform for the treatment of chronic obstructive pulmonary disease.
The primary endpoint of the study is to compare the annualised rate of moderate and severe COPD exacerbations during a 52-week treatment period, with the aim of demonstrating the superiority of Flutiform (fluticasone and formoterol)over formoterol in a pressurised metered dose inhaler. Mundipharma hopes to recruit 1,530 patients.
Flutiform is currently marketed for bronchial asthma in 12 European countries, and is approved in Israel, Australia and Hong Kong. Skyepharma chief executive Peter Grant said that “we look forward to the results of the COPD trials and to the continued roll-out of Flutiform by Mundipharma, which is already providing many asthma patients with a new and effective treatment option”.
COPD will become an increasingly important area for SkyePharma given that two new GlaxoSmithKline combination products for the disease - Breo Ellipta (fluticasone furoate/vilanterol) and Anoro Ellipta (umeclidinium/vilanterol) – have been developed using the London-headquartered company’s technology.