FDA approves Asmanex for once-daily treatment of asthma


The FDA ( Food and Drug Administration ) has approved the use of Asmanex Twisthaler 220 mcg ( Mometasone furoate inhalation powder ) for the first-line maintenance treatment of asthma as preventive therapy in patients 12 years of age and older.

Clinical studies with Asmanex have shown improvement in lung function, decreased use of rescue medication, decreased incidence of nighttime awakenings and improvements in daytime symptoms such as coughing and wheezing.

Mometasone furoate, the active ingredient in Asmanex, was first introduced in the U.S. in 1987 as dermatologic ointment, Elocon ( Mometasone furoate ointment ) and in 1997 as the nasal spray, Nasonex ( Mometasone furoate monohydrate ).

The most common side effects of Asmanex include: headache, allergic rhinitis, pharyngitis, upper respiratory infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, dyspepsia, myalgia, abdominal pain, and nausea.

Recommended starting dose of Asmanex is one inhalation daily in the evening for patients previously treated with bronchodilators alone or inhaled corticosteroids.
For patients previously maintained on oral corticosteroids, the recommended starting dose of Asmanex is two inhalations twice daily.

Asmanex has been awaiting approval from the U.S. Food and Drug Administration since 1998.

Source: Schering-Plough, 2005


XagenaMedicine2005