Last week, Merck & Co.’s Schering Corp. announced that they have received approval from the US Food and Drug Administration for DULERA®, a fixed-dose combination product of mometasone and formoterol, indicated for controller treatment of asthma in patients 12 years and older.
Two controlled studies comparing DULERA® with mometasone and placebo support the FDA’s decision. Merck reports significant increases in FEV1 for the AUC0-12hrs in both trials at week 12, with demonstrated persistence at week 26 in one trial. Side effects were similar to other combination products and include headache, nasopharyngeal irritation, and sinusitis. The black box warning for long-acting β-2 agonists is included in the FDA approval. (For the DULERA® medication guide, click here.) The medication comes in two fixed dose strengths and is expected to be available in the US by the end of this month.
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