Approved February 2002
Reversible obstructive airway disease
Xopenex is approved for the treatment or prevention of bronchospasm in adults and children ages six years and older, who suffer from reversible obstructive airway disease, such as asthma. Xopenex has been approved since 1999 for use in adults and children ages 12 and over. The pediatric indication was extended in February 2002. The inhaled solution is to be administered three times daily, using a nebulizer system.
The American Lung Association estimates that 26 million Americans have been diagnosed with asthma, the most common reversible obstructive airway disease. Of these, 8.6 million are under the age of 18.
The approval of Xopenex is supported by one of the largest pediatric asthma studies ever conducted with a beta-agonist. Double-blind, placebo-controlled trials involving 338 subjects were designed to modify the approved adult and adolescent dosages for safe and effective use in children. Both doses of Xopenex tested in subjects ages six to 11 years old were clinically comparable to larger doses of a competitive treatment, for onset of effectiveness and duration of effect.
Prior to it's original approval date, the safety and efficacy of Xopenex was evaluated in a double-blind, placebo-controlled study in adults and adolescents with asthma. On both the first and last days of the study, Xorenex provided subjects with equivalent or superior relief compared to larger doses of a competitive treatment.
Adverse events associated with the use of Xopenex may include (but are not limited to) the following:
Xopenex (levalbuterol HCl) inhalation solution binds to human beta-adrenergic receptors on the smooth muscles of all airways. This relaxes the airways, which protects against bronchoconstrictor challenges.
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