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FDA approves new combination asthma therapy

The FDA has recently approved a new fixed-dose combination mometasone furoate and formoterol fumarate dihydrate drug for use in patients aged 12 years and older with asthma.

Merck’s Dulera inhalation aerosol is a pressurized metered-dose inhaler with a built-in numeric counter showing the number of remaining doses and will be available in two strengths, with each one containing 5 mcg of formoterol fumarate and either 100 mcg or 200 mcg of mometasone furoate.

Results from two phase 3 randomized clinical trials formed the basis for the FDA’s decision. One trial compared Dulera 100 mcg/5 mcg to its individual components and placebo, and the second study compared Dulera 200 mcg/5 mcg with the 100 mcg/5 mcg dose.

Data indicated that patients receiving either dose had considerably enhanced lung function from baseline after 12 weeks when compared with placebo in the first trial and mometasone furoate in both trials. The researchers reported that these marked improvements continued through 26 weeks in the first trial.

The two trials lasted between 12 and 26 weeks and involved 1,509 patients aged 12 years and older with persistent asthma that was uncontrolled on medium- or high-dose inhaled corticosteroids. Researchers introduced mometasone furoate to patients during a 2- to 3-week period to establish a certain level of asthma control, and medications were administered in two inhalations twice daily via metered-dose inhalers.

Results from the studies also revealed that nasopharyngitis, sinusitis and headache were the most commonly reported adverse events and occurred in at least 3% of patients. Dysphonia was also a commonly reported adverse event in this long-term study.

“Despite the advances made in the treatment of asthma in recent years, many patients may still not be well-controlled on their current therapies,” Michael S. Blaiss, MD, clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center in Memphis, said in a press release. “Asthma control is an important treatment goal and Dulera provides a new option for physicians to help manage this chronic condition in appropriate patients.”

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