General Information

Foradil is a bronchodilator that belongs to the long-acting beta2-adrenergic receptor agonist class of compounds. Novartis' Foradil Aerolizer was approved in February 2001 for the maintenance treatment of asthma and the prevention of bronchospasm in reversible obstructive airways disease. Foradil is also indicated for the acute prevention of exercise-induced bronchospasm (EIB), when administered on an occasional, as needed basis.

In September 2001, a second FDA approval was obtained - the Foradil Aerolizer can now be used for long term administration in the maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema.

Foradil is administered via a dry powder inhaler called the Aerolizer, which unlike traditional metered-dose inhalers, provides patients with the reassurance that they are in control of dosing. The Aerolizer offers patients little resistance to inhalation, and produces a whirring noise which signals that the drug is being inhaled. Patients can taste the powder and then open the device to check that they have inhaled all of the dose.

Asthma is a chronic inflammatory lung disease that affects 15 million Americans. According to the World Health Organization, each year 180,000 people die from asthma worldwide. The disease is characterized by shortness of breath, wheezing, tightness in the chest, and a cough that lasts more than a week.

COPD is a common chronic lung disease and a leading cause of mortality worldwide, with 2.25 million deaths a year. By 2025, the World Health Organization estimates that COPD will be the third leading cause of death globally. Since both asthma and COPD are chronic conditions, the goal of treatment is management and improvement of quality of life, rather than cure.

Clinical Results

The effectiveness of Foradil as a treatment for asthma was evaluated in five key trials involving more than 7,000 subjects, including over 1,600 mild to moderate asthmatics. In these placebo-controlled trials, Foradil was administered in 12 and 24 mcg twice daily doses.

Overall, these studies demonstrated both dosages of Foradil to be significantly better than placebo at improving lung function and quality of life in asthmatic subjects. Foradil provided subjects with clinically significant bronchodilation for a 12 hour period.

Clinical trials were also conducted to compare Foradil to the compound ipratropium bromide in subjects with COPD. Results showed that Foradil was significantly superior at reducing clinical symptoms and improving quality of life scores.

Side Effects

Adverse reactions to treatment with Foradil are similar to those observed with other selective beta2-adrenoceptor agonists. These effects can include (but are not limited to) the following:

• Angina
• Muscle cramps
• Rapid or irregular heartbeat
• Nervousness
• Headache
• Tremor
• Dizziness

Mechanism of Action

Formoterol fumarate is a long-acting selective beta2-adrenergic receptor agonist (beta2-agonist). Inhaled formoterol fumarate acts locally in the lung as a bronchodilator.

The pharmacologic effects of beta2 adrenoceptor agonist drugs, including formoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels cause relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. (from Foradil Prescribing Information)

Additional Information

For additional information on Foradil, please visit Novartis or the product web site at www.foradil.com.