Wilmington, DE – February 24, 2007 – New data demonstrated the maintenance combination asthma therapy, SYMBICORT® (budesonide/formoterol fumarate dehydrate), provides a rapid, clinically significant bronchodilatory response, or opening of the airways, defined as the median time to achieve ≥15% improvement in lung function within 15 minutes after administration. In addition, these data demonstrated that in comparison to its monocomponents (budesonide and formoterol) and placebo, SYMBICORT and the other treatment groups containing formoterol had a faster bronchodilatory response than budesonide or placebo. The combined study results, involving patients with mild-to-severe persistent asthma who previously required treatment with inhaled corticosteroids (ICS), were presented today at the annual meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI) held in San Diego, February 23-27, 2007.
SYMBICORT is a newly approved, twice-daily, inhaled combination therapy containing budesonide, a corticosteroid, and formoterol, a rapid and long-acting beta2-agonist. It is indicated for the long-term maintenance treatment of asthma in patients ages 12 and older. SYMBICORT is not indicated in patients whose asthma can be successfully managed by inhaled corticosteroids along with occasional use of inhaled, short-acting beta2-agonists.
Additional data from these studies presented at AAAAI showed SYMBICORT provided significantly greater improvements in asthma control compared to its monocomponents (budesonide or formoterol) or placebo in patients with mild-to-moderate asthma who required an ICS. In patients with moderate-to-severe asthma who required an ICS, SYMBICORT also demonstrated significantly greater improvement in lung function compared to its monocomponents (budesonide or formoterol) or placebo.
"With an estimated 20 million patients currently suffering from asthma in the U.S., SYMBICORT represents an exciting new treatment option and a welcome addition to our respiratory franchise," said Chris O'Brien, Senior Director, Medical Science, AstraZeneca. "We are dedicated to the development of new, effective treatments to improve lung health and are looking forward to making SYMBICORT available in the U.S."
Study Results
Abstract #974: Bronchodilatory response rate was investigated in two 12-week, randomized double-blind, placebo-controlled, multicenter studies. Study I involved 596 patients with moderate-to-severe asthma who were randomized after a two-week run-in (two inhalations bid budesonide pMDI 80 mg), into one of five groups, including: treatment with two inhalations twice daily with SYMBICORT (budesonide/formoterol pMDI) 160/4.5 micrograms (mg), budesonide pMDI 160 + formoterol dry powder inhaler (DPI) 4.5 mg in separate inhalers, budesonide pMDI 160 mg, formoterol DPI 4.5 mg, or placebo. Study II involved 480 patients with mild-to-moderate asthma who were randomized after a two-week run-in (current asthma therapy discontinued) into one of four groups, including: treatment with two inhalations twice daily with SYMBICORT (budesonide/formoterol pMDI) 80/4.5 mg, budesonide pMDI 80 mg, formoterol DPI 4.5 mg, or placebo. Bronchodilatory response was measured by the median time to achieve ≥15% improvement in forced expiratory volume in one second (FEV1) – how much air a person can exhale during a forced breath in the first second of exhalation, which is a measure of how well the lungs are functioning – after medication was taken.
Results showed that after the first dose of treatment (day of randomization), the median time to ≥15% FEV1 improvement was significantly earlier (P<.001, Wilcoxon test) with SYMBICORT pMDI versus budesonide pMDI and placebo and similar to formoterol in both studies.
Abstract #972: Changes in asthma control measures were investigated in a 12-week, multicenter, double-blind, placebo-controlled study evaluating 480 patients aged 12 and older with mild-to-moderate persistent asthma receiving inhaled corticosteroids. Patients were randomized to receive treatment with two inhalations twice daily with SYMBICORT (budesonide/formoterol pMDI) 80/4.5 mg, budesonide pMDI 80 mg, formoterol DPI 4.5 mg, or placebo after a two-week run-in. The data demonstrated that SYMBICORT resulted in significantly greater improvements in measures of asthma control (i.e., day/night time peak expiratory flow (PEF) – the maximum speed of a forced breath, day/night time symptom scores, percent of symptom-free days, awakening-free nights, rescue medication-free days, and asthma control days) versus placebo, and greater improvements in some measures of asthma control versus its monocomponents (budesonide or formoterol).
Abstracts #7&17: The safety and treatment effects of SYMBICORT (budesonide/formoterol pMDI) on lung function versus its monocomponents (budesonide and formoterol) or placebo were assessed in a 12-week randomized, double-blind, double-dummy, placebo-controlled, multicenter study evaluating 596 patients 12 years and older with moderate-to-severe asthma who were previously treated with inhaled corticosteroids. After a two-week run-in period (two inhalations budesonide pMDI 80 μg bid), symptomatic patients were randomized to receive treatment with two inhalations twice daily with one of five treatments including SYMBICORT (budesonide/formoterol pMDI) 160/4.5 μg, budesonide pMDI 160 μg + formoterol DPI 4.5 μg in separate inhalers, budesonide pMDI 160 μg, formoterol DPI 4.5 μg, or placebo. Results showed SYMBICORT provided improvements in lung function (measured by morning predose FEV1, 12-hour mean postdose FEV1, and morning and evening PEF) significantly greater than its monocomponents (budesonide and formoterol) or placebo and was well tolerated.
About Asthma
Asthma is a chronic inflammatory disease of the airways characterized by excessive sensitivity of the lungs, or increased reactivity of the airways, to various environmental stimuli or triggers. The inflammation results in narrowed, swollen airways, increased mucus, and frequently is accompanied by tightening of the muscles in the airways, or bronchoconstriction, causing difficulty breathing and the familiar wheeze often associated with the disease. If not properly managed, asthma can be life-threatening.
It is estimated that more than 20 million Americans have asthma, and despite the availability of many treatments for adults with asthma and guidelines on the effective treatment of asthma, the disease is still poorly controlled. A retrospective claims database analysis of nearly 4,000 patients found that patients experienced asthma attacks (defined as asthma-related emergency department visits, hospitalizations or oral corticosteroid bursts) at a steady rate over a four-year period. Additionally, asthma patients who have experienced an asthma attack are twice as likely to experience additional exacerbations as patients who have not. The annual direct healthcare cost of the disease in the U.S. is approximately $11.5 billion. Indirect costs (e.g., lost productivity due to missed days at school or work) add another $4.6 billion, for a total cost of $16.1 billion.
Important Safety Information
Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SYMBICORT should only be used for patients not adequately controlled on other asthma-controller medications (e.g., low-to-medium dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies. Data from a large placebo-controlled US study that compared the safety of another long-acting beta2-adrenergic agonist (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a long-acting beta2-adrenergic agonist), one of the active ingredients in SYMBICORT (see WARNINGS).
SYMBICORT is not indicated for the relief of acute bronchospasm.
SYMBICORT should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.
Particular care is needed for patients who are transferred from systemically active corticosteroids. Death due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Patients who are receiving SYMBICORT twice daily should not use additional formoterol or other long-acting inhaled beta2-agonists for any reason.
Common adverse events reported in clinical trials, occurring in ≥5% of patients, regardless of relationship to treatment, included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.
Please see full Prescribing Information and visit www.SYMBICORT-US.com.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture, and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca recently expanded eligibility requirements for its Patient Assistance Program to allow a family of four earning $60,000 or individuals earning $30,000, who do not have prescription drug coverage, to qualify to get their AstraZeneca medicines for free.
AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology, and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
AstraZeneca Respiratory is dedicated to the development of new, effective treatments that help improve lung health and enhance the lives of adults and children living with asthma. Through innovative respiratory products, including SYMBICORT®, AstraZeneca is providing patients with effective treatment options to help manage their condition.
For more information about AstraZeneca, please visit: www.astrazeneca-us.com.