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| |  New Bronchodilator, Foradil Aerolizer, Approved For Maintenance Treatment Of Asthma EAST HANOVER, N.J. -- February 16, 2001 -- Novartis Pharmaceuticals Corporation announced today that the Food and Drug Administration has approved Foradil® Aerolizer™ (formoterol fumarate inhalation powder) a selective beta2-agonist for the maintenance treatment of asthma and prevention of bronchospasm. The product is approved for use in adults and children five years of age and older with reversible obstructive airways disease, including patients with symptoms of nocturnal asthma who require regular treatment with inhaled, short-acting beta2-agonists. Foradil Aerolizer is also indicated for the acute prevention of exercise-induced bronchospasm in adults and children 12 years of age and older, when administered on an occasional, as-needed basis. Administered twice daily (morning and evening), Foradil Aerolizer works quickly to provide asthma patients long-acting symptom control (12-hour period). However, Foradil Aerolizer is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting beta2-agonists. Foradil Aerolizer has not been studied as a rescue medication and, therefore, should not be used for that indication. "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 Dr. 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. Foradil Aerolizer 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." Foradil capsules are administered via a new device called the Aerolizer Inhaler-an easy-to-use delivery system that allows patients to "see, hear, feel" that they have correctly taken their medication. 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. "The safety and efficacy of Foradil Aerolizer, combined with the unique Aerolizer delivery system, provides physicians and asthma patients with a new option that may allow them to better manage their asthma," said Dr. Umit Yegen, associate director, clinical research, Novartis Pharmaceuticals Corporation. "Novartis is proud to offer asthma patients such a promising new treatment to control their disease." In two pivotal, randomized, multicenter, double-blind studies with mild-moderate asthma patients 12 years of age and older, Foradil Aerolizer 12 mcg twice daily provided clinically significant bronchodilation throughout the 12-hour observation period. Foradil Aerolizer was found to have an onset of action similar to albuterol (a short-acting beta2-agonist); however, Foradil Aerolizer has not been studied as a rescue medication and, therefore, is not approved for that indication. The clinical research also confirmed that Foradil Aerolizer 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 Foradil Aerolizer 12 mcg twice daily produced clinically and statistically greater bronchodilation than placebo. Protection against exercise-induced bronchospasm (defined as >20 percent fall in FEV1) was examined in two randomized, single-dose, double-blind studies in patients 12 years of age and older. Foradil Aerolizer 12 mcg prevented exercise-induced bronchospasm in the vast majority of patients for up to 12 hours after dosing. Adverse reactions with Foradil Aerolizer were similar in nature to those experienced with other selective beta2-agonists, such as tachycardia, tremor, dizziness, insomnia and abdominal pain. Foradil Aerolizer is not a substitute for inhaled or oral corticosteroids. Asthma, a chronic inflammatory lung disease, affects as many as 17 million Americans and is responsible for 5,000 deaths annually. Children account for approximately one-third of the diagnosed cases, and asthma is the second most common cause of school absenteeism, after the common cold. The condition is characterized by shortness of breath, wheezing, tightness in the chest and a cough that lasts more than a week. Since asthma is a chronic condition, the goal for treatment is management rather than cure.
Related Link: Novartis Pharmaceuticals Corporation.
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