A Phase 3 trial of Flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of COPD has been initiated, according Mundipharma. The 52-week randomized, double-blind EFFECT study compare Flutiform 250/10 μg and Flutiform 125/5 μg with formoterol 12 μg. Flutiform is approved in Europe for the treatment of asthma; it is not approved for the treatment of COPD.
Mundipharma Chief Marketing Officer Georg Toufar commented, “The Mundipharma network of independent associated companies is committed to expanding our product offering in respiratory diseases including COPD, a chronic and debilitating disease which is predicted to become the third leading cause of death worldwide by 2030.”
Mundipharma acquired rights to market Flutiform in Europe from developer Skyepharma. In 2011, Sanofi acquired rights to market the inhaler in Mexico and Central and South America.
Read the Mundipharma press release.