Manufactured by the drug maker Schering-Plough Corp., it's the first once-daily, inhaled corticosteroid medicine for asthma for once-daily maintenance treatment of asthma in children as young as 4.
The Kenilworth-based company said Asmanex is already approved by the U.S. Food and Drug Administration at higher dosage strength for maintenance treatment of asthma as preventive therapy in patients 12 years of age and older.
However, the dosage for children aged 4 to 11, 110 micrograms, is half the adult dose. Other products currently available in market for children as young as 6, must be taken more times a day.
Asmanex Twisthaler employs an inhalation-driven device that does not use a propellant, thus eliminating the need for hand-breath coordination. It also gives patients a numeric dose counter that provides a visual indication of the remaining doses.
However, the company added that Asmanex is not indicated for the relief of acute bronchospasm or in children less than 4 years of age. Also, the therapy should not be used to treat sudden asthma attacks.
The most common side effects with Asmanex Twisthaler include headache, nasal allergy symptoms, sore throat, upper respiratory infection and sinus infection. In some cases it can also cause growth retardation in children in addition to fungal infections of the mouth, painful menstrual periods, muscle and bone pain, back pain, and upset stomach.
Asthma is a chronic disorder characterized by inflammation of the air passages, resulting in the temporary narrowing of the airways that transport air from the nose and mouth to the lungs.
Pediatric asthma affects more than one in every 20 children, and it is the third leading cause of hospitalization among children under the age of 15. It is also the most common cause of school absenteeism due to chronic disease, and it accounts for an annual loss of more than 14 million school days per year.
