Merck announced that the FDA has approved Dulera (mometasone furoate and formoterol fumarate dihydrate) inhalation aerosol for the treatment of asthma in patients ≥12 years of age. This approval was based on clinical data from two Phase 3 studies that evaluated Dulera in 1,509 patients ≥12 years of age with persistent asthma uncontrolled on medium or high dose inhaled corticosteroids.

Results from both trials showed patients receiving Dulera experienced significant improvement from baseline in lung function (mean area under the concentration-time curve for forced expiratory volume in 1 second, measured from 0 to 12 hours [FEV1 AUC0-12h]) at week 12 compared to mometasone furoate (Trial 1 and 2) and placebo (Trial 1). In Trial 1, these differences were maintained through week 26. Additionally, a significantly greater increase in the mean trough FEV1 was observed for Dulera 100mcg/5mcg compared to formoterol 5mcg as well as to placebo in Trial 1. In Trial 2, a greater numerical increase in the mean trough FEV1 was observed for Dulera 200mcg/5mcg compared to Dulera 100mcg/5mcg and mometasone furoate 200mcg.

Dulera is a pressurized metered-dose inhaler with a built-in numeric counter that shows the number of remaining doses. Dulera is expected to be available by the end of July 2010 in mometasone furoate/formoterol fumarate 100mcg/5mcg and 200mcg/5mcg dosage strengths.

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