According to Mundipharma, three Phase 3 studies of the Flutiform fluticasone propionate/formoterol fumarate metered dose inhaler (MDI) have demonstrated that the product “had comparable efficacy in improving the lung function and a similar safety profile to budesonide/formoterol, a licensed combination asthma therapy,” “was as effective in treating asthma as fluticasone and formoterol administered concurrently via separate inhalers,” and “was more effective than each of the compounds administered alone on measures of lung function.” The data were presented at the 2011 European Respiratory Society (ERS) meeting.
Mundipharma licensed the rights to market Flutiform in most of the world, excluding the Americas and Japan, from Skye Pharma in 2006. A decision on the European marketing authorization application (MAA) for Flutiform is expected by the end of 2011. In the US, the FDA issued a complete response letter for Flutiform in January 2010 and in June of that year requested significant additional studies. Abbott returned the US rights to Skye a few months later.
David Price from the Centre of Academic Primary Care at the University of Aberdeen commented: “The benefits of ICS/LABA combination therapies are well established, with international clinical guidelines recognising their efficacy and role in improving patient adherence with ICS and asthma outcomes. The data presented at ERS show the good efficacy and safety profile of the fluticasone/formoterol combination, which for the first time brings together these two molecules in a widely-used device, demonstrating its potential to become a valuable new treatment option for asthma patients.”
Read the Mundipharma press release.
