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Merck to ship Dulera inhaler for asthma

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WHITEHOUSE STATION, N.J. — Merck next month plans to release Dulera Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older.

The pharmaceutical giant said Thursday that Dulera Inhalation Aerosol (mometasone furoate and formoterol fumarate dihydrate) has received approval from the Food and Drug Administration. Plans call for the drug to be available in retail pharmacies nationwide by the end of July.

Dulera is a pressurized metered-dose inhaler with a built-in numeric counter that shows the number of remaining doses. It will be available for patients 12 years of age and older in two strengths: 100 mcg/5 mcg and 200 mcg/5 mcg. Each inhalation contains 5 mcg of formoterol fumarate and either 100 mcg or 200 mcg of mometasone furoate. The recommended starting dose is based on prior asthma therapy. The maximum daily recommended dose is two inhalations of Dulera 200 mcg/5 mcg twice daily every day in the morning and evening.

Merck noted that Dulera isn’t indicated for the relief of acute bronchospasm. The medication combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate). The company said the FDA approval of Dulera is based, in part, on Phase III studies that evaluated the safety and efficacy of the drug in patients 12 years of age and older with persistent asthma.

"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 Blaiss, M.D., clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center, said in a statement released by Merck. "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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