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.Formoterol powder
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.
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)
