March 2001
ROCKVILLE, Md. - The Food and Drug Administration (FDA) approved formoterol fumarate inhalation powder (Foradil Aerolizer, Novartis Pharmaceuticals Corp.) for the maintenance treatment of asthma and prevention of bronchospasm in children.
This selective ß2-agonist is indicated for use in children 5 years and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma who require regular treatment with inhaled, short-acting ß2-agonists.
Formoterol fumarate inhalation powder is also indicated for the acute prevention of exercise-induced bronchospasm in children 12 and older, when administered on an occasional, as-needed basis. Administered twice daily (morning and evening), formoterol fumarate inhalation powder works quickly to provide asthma patients long-acting symptom control (12-hour period). However, formoterol fumarate inhalation powder is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting ß2-agonists. Formoterol fumarate inhalation powder has not been studied as a rescue medication and, therefore, should not be used for that indication.
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"Asthma is a very serious medical condition that often robs patients of their health, energy and freedom, and if not properly managed can lead to hospitalization," said William E. Berger, MD, MBA, clinical professor, department of pediatrics division of allergy and immunology, University of California, Irvine. "With proper asthma management, patients can reclaim their lives and perform at their peak levels. Formoterol fumarate inhalation powder is an effective therapy that provides patients with a long duration of action, which may provide some patients better symptom control than they achieve with their current medications."
Formoterol fumarate inhalation powder capsules are administered by a new device called the Aerolizer Inhaler. A concern with traditional metered-dose inhalers is that patients are not able to confirm that they have taken the correct dose of medication. In contrast, the Aerolizer Inhaler can be visually inspected so patients can confirm they have received the full dose.
Another feature of the Aerolizer Inhaler is that it produces a whirring noise, which signals that the drug is being dispensed.
In two pivotal, randomized, multicenter, double-blind studies with mild to moderate asthma patients 12 years and older, formoterol fumarate inhalation powder 12 µg twice daily (BID) provided clinically significant bronchodilation throughout the 12-hour observation period. Formoterol fumarate inhalation powder was found to have an onset of action similar to albuterol, but it has not been studied as a rescue medication.
The clinical research also confirmed that formoterol fumarate inhalation powder provides protection against nocturnal asthma symptoms, resulting in fewer nighttime awakenings and less use of nighttime rescue medication, as compared with placebo.
A 12-month multicenter, randomized, double-blind, parallel group study of pediatric patients (ages 5-12 years) demonstrated that formoterol fumarate inhalation powder 12 µg BID produced clinically and statistically greater bronchodilation than placebo.
Protection against exercise-induced bronchospasm was examined in two randomized, single-dose, double-blind studies in patients 12 years and older. Formoterol fumarate inhalation powder 12 µg prevented exercise-induced bronchospasm in most patients for up to 12 hours after dosing.
Adverse reactions with formoterol fumarate inhalation powder were similar to those experienced with other selective b2-agonists, such as tachycardia, tremor, dizziness, insomnia and abdominal pain.
Formoterol fumarate inhalation powder is not a substitute for inhaled or oral corticosteroids.
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