Foradil Aerolizer now available for the maintenance treatment of asthma.
The American Academy of Allergy, Asthma & Immunology estimates there are more than 17 million Americans diagnosed with asthma, accounting for more than $9.8 billion annually in direct health-care costs. Since asthma is a chronic condition, the goal for treatment is management, rather than cure. Novartis' Foradil Aerolizer (formoterol fumarate inhalation powder), a long-acting, selective beta2-agonist, offers a new option for asthma sufferers.
The Food & Drug Administration has approved formoterol for long-term, twice-daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in adults and children five years of age and older with reversible obstructive airways disease. That includes patients with nocturnal asthma, who require regular treatment with inhaled, short-acting, beta2-agonists. Formoterol is also indicated for the acute prevention of exercise-induced bronchospasm (EIB) in adults and children 12 years of age and older, when administered on an occasional, as-needed, basis. It is not indicated for patients whose asthma can be managed by occasional use of inhaled, short-acting, beta2-agonists.
"We know asthma is an inflammatory disease, but there seems to be a bronchospastic component, so I see Foradil as an aid or an augmenter to the controller therapy available now," said John Oppenheimer, M.D., an investigator of the study. He is a clinical associate professor at the University of Medicine & Dentistry of New Jersey and director of clinical research of Pulmonary & Allergy Associates, Morristown, N.J. "People already using an inhaled anti-inflammatory can add this long-acting bronchodilator to aid them at maintaining or getting better control," he added.
Formoterol is only the second agent in this new class of long-acting bronchodilators, the first being Serevent (salmeterol, GlaxoSmithKline). The rapid onset of action of inhaled formoterol (one to three minutes) differentiates it from inhaled salmeterol, which has an onset of action of 10 to 20 minutes.
The FDA based its approval on results of five clinical studies involving more than 1,600 patients with mild to moderate asthma. In one multicenter, double-blind, parallel-group study, 541 patients (aged 12 to 75 years) were randomized to receive formoterol 12 mcg or 24 mcg b.i.d.; albuterol, 180 mcg q.i.d.; or a placebo for 12 weeks. Formoterol demonstrated greater improvement as compared with albuterol and placebo in many secondary efficacy endpoints, including improved combined and nocturnal asthma scores, fewer nocturnal awakenings, less use of rescue medication, and higher morning and evening peak flow rates.
Oppenheimer voiced concern over recent reports that indicate traditional metered-dose inhalers aren't being used correctly, and he sees formoterol's unique dry powder delivery system as the "wave of the future." According to the company, the Aerolizer inhaler allows patients to "see, hear, feel" that they have correctly taken their medication. The inhaler can be visually inspected to ensure that the complete dose has been taken; patients can taste the powder (lactose has been added), and the inhaler produces a whirring noise that signals the drug is being dispensed.
Adverse reactions to formoterol are similar in nature to those of other selective beta2-agonists. They may include tremor, muscle cramps, insomnia, tachycardia, hypokalemia, and hyperglycemia.
Formoterol should not be used to treat acute symptoms of asthma. For the maintenance treatment of asthma in adults and children five years of age and older, the usual dosage is the inhalation of the contents of one 12-mcg capsule every 12 hours using the inhaler. For the prevention of EIB for adults and adolescents 12 years of age or older, the usual dosage is the inhalation of one 12-mcg capsule at least 15 minutes before exercise on an occasional, as-needed, basis. Additional doses should not be used for 12 hours after administration of the drug.
Tammy Chernin. New long-acting bronchodilator also provides rapid onset. Drug Topics 2001;6:15.