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Inhalation solution approved for bronchospasm in children. (Product Marketplace).

Sepracor announces that the U.S. Food and Drug Administration (FDA) has approved Xopenex[R] brand levalbuterol HCI inhalation solution for the treatment or prevention of bronchospasm in children 6 to 11 years old with reversible obstructive airway disease, such as asthma. Xopenex will be marketed for use in a nebulizer at dosage strengths of 0.31 and 0.63 mg for pediatric patients. This product has been marketed at dosage strengths of 0.63 and 1.25 mg for patients 12 years of age and older since May 1999.

Results of a multicenter, randomized, double-blind, placebo-controlled pediatric study were included in the supplemental New Drug Application (sNDA) submission to the FDA in March 2001. In one of the largest pediatric asthma studies ever conducted for a beta-agonist (n = 338), the safety and efficacy of levalbuterol inhalation solution were evaluated at dosage strengths of 0.31 and 0.63 mg, and racemic albuterol inhalation solution at dosage strengths of 1.25 and 2.5 mg, compared with placebo, in patients with mild to moderate asthma. Both pediatric dosage strengths of levalbuterol were found to be safe and effective, according to lead investigator Henry Milgrom, MD. The study was published in the December 2001 issue of The Journal of Allergy and Clinical Immunology.

The 0.31-mg dose is the lowest pediatric Xopenex dose approved by the FDA for the treatment or prevention of bronchospasm. This dose was found to be effective and to have an acceptable beta-mediated side effect profile. The recommended dosage for patients 6 to 11 years of age is 0.31 mg administered three times a day by nebulization. Routine dosing should not exceed 0.63 mg three times a day.

Adverse events that occurred in [greater than or equal to]2% of patients receiving Xopenex inhalation solution or racemic albuterol and more frequently than patients receiving placebo included flu syndrome, tachycardia or increased heart rate, nervousness, and tremor.

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Comment:Inhalation solution approved for bronchospasm in children. (Product Marketplace).
Publication:Ear, Nose and Throat Journal
Article Type:Brief Article
Geographic Code:1USA
Date:Mar 1, 2002
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