Regulatory filing in Europe is expected during the first quarter of 2010.
SkyePharma and Mundipharma have reported positive results from a Phase III trial with the inhaled asthma drug combination, Flutiform. The treatment has now completed European development, and submission for regulatory approval in the EU is scheduled to take place during the next year’s first quarter.
Mundipharma negotiated commercialization rights to Flutiform outside the Americas and Japan. SkyePharma’s U.S. partner for Flutiform, Abbott, submitted the drug for FDA approval in March. In Japan the therapy is undergoing Phase II development by partner, Kyorin Pharmaceutical.
Flutiform is a fixed-dose combination of fluticasone propionate and formoterol fumarate and is administered using a metered-dose inhaler. The reported Phase III trial included 529 patients suffering from severe, persistent, and reversible asthma. It compared the treatment of asthma using different doses of Flutiform with Flixotide (fluticasone) and Foradil (formoterol) administered concurrently or Flixotide alone. The results confirmed the efficacy of high-dose Flutiform (fluticasone 500 micrograms and formoterol 20 micrograms) in the improvement of forced expiratory volume.