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)
