Merck announced that the US Food and Drug Administration (FDA) has approved Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol, a new fixed-dose combination asthma treatment for patients 12 years of age and older. Dulera is not indicated for the relief of acute bronchospasm. Dulera combines an inhaled corticosteroid (mometasone furoate) with a long-acting beta2-agonist (formoterol fumarate). The approval of Dulera is based, in part, on phase III studies that evaluated the safety and efficacy of Dulera 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,” said Michael S. Blaiss, M.D., clinical professor of paediatrics and medicine at the University of Tennessee Health Science Center, Memphis, Tennessee. “Asthma control is an important treatment goal and Dulera provides a new option for physicians to help manage this chronic condition in appropriate patients.”

Dulera is indicated for the treatment of asthma in patients 12 years of age and older. Dulera is not indicated for the relief of acute bronchospasm.

Long-acting beta2-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in Dulera, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in paediatric and adolescent patients. Therefore, when treating patients with asthma, Dulera should only be used for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue Dulera) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use Dulera for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids.

“As a leader in researching and developing new treatments for respiratory diseases, including asthma, Merck is committed to bringing forth medicines that help meet the needs of healthcare professionals and their patients,” said James E. Fish, M.D., executive director, Global Scientific Affairs, Merck Research Laboratories. “Dulera represents an important part of this ongoing commitment.”

Dulera is a pressurized metered-dose inhaler with a built-in numeric counter that shows the number of remaining doses. Dulera will be available for patients 12 years of age and older in two strengths: Dulera 100 mcg/5 mcg and Dulera 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. Dulera is expected to be available in retail pharmacies nationwide by the end of July 2010.