Newly presented data indicate that treatment with SYMBICORT? (budesonide/formoterol fumarate dihydrate) inhalation aerosol results in significantly greater improvements in lung function, and a lower risk of asthma worsening episodes, compared to budesonide and/or formoterol used alone. In addition, data also showed that SYMBICORT was generally well-tolerated, with an adverse event profile similar to that of its individual components. These study results, involving patients with mild to moderate persistent asthma, were presented today at the American College of Allergy, Asthma & Immunology’s (ACAAI) annual scientific sessions held in Philadelphia on November 9-15, 2006.
SYMBICORT is a newly approved, twice-daily, inhaled combination therapy containing budesonide (BUD), a corticosteroid, and formoterol (FM), 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 for patients not adequately controlled on other asthma-controller medications or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.
?Asthma is a serious, sometimes life-threatening, disease that can greatly impact lung health and function when not properly managed,? said Jonathan Corren, M.D., Clinical Associate Professor of Medicine and Pediatrics Division of Clinical Immunology and Allergy, University of California, Los Angeles. ?These data demonstrate that in patients with persistent asthma symptoms, SYMBICORT provides advantages over its individual components in improving lung function and asthma control, as well as preventing asthma attacks.?
SYMBICORT was approved by the U.S. Food and Drug Administration on July 21, 2006. AstraZeneca plans to launch the drug in the U.S. in mid-2007 in a pressurized metered dose inhaler (pMDI), a device that delivers the medication in an aerosol form.
The 12-week, randomized, double-blind, placebo-controlled trial involved a total of 480 patients age 12 years or older with mild to moderate persistent asthma who were previously treated with an inhaled corticosteroid. Patients were randomized to twice-daily treatment in one of four treatment groups: SYMBICORT (BUD/FM pMDI) 160/9 micrograms (mg); BUD 160mg administered via pMDI; FM 9mg delivered via a dry powder inhaler (DPI); or placebo.
Lung function was assessed throughout the 12-week study based on the following measures:
Predose (before treatment) forced expiratory volume in one second (FEV1) ? how much air a person can exhale during a forced breath in the first second of exhalation
Twelve-hour mean (or average) FEV1 after dosing on day 1 and after weeks 2 and 12
Predose morning and evening peak expiratory flow (PEF) ? the speed of a forced breath
Improvements in predose FEV1 and morning and evening PEF over 12 weeks compared to baseline were significantly greater in the SYMBICORT group compared to all other groups (P=.005 and P<.001, respectively). Improvements in 12-hour average postdose FEV1 were significantly greater (P<.001) in the SYMBICORT group compared to BUD or placebo groups at each time point measured. Overall, the improvements in lung function parameters were maintained with SYMBICORT and did not diminish over time. In addition, the incidence of asthma worsening (based on predefined criteria) was lower (P<.001) in the SYMBICORT group compared to FM or placebo groups. The adverse events (AEs) profile for SYMBICORT was similar to that of BUD and FM. Most AEs were of mild or moderate intensity. The overall incidence of asthma-reported AEs was 2.5 percent, though no asthma AEs were reported in the SYMBICORT group. Additionally, there were no clinically significant differences between treatment groups in changes from baseline for postdose electrocardiograms (ECGs), laboratory values, results of Holter monitor assessments, and vital signs. Treatment related adverse events (reported by >/=0.5 percent of patients) included headache, tremor, cough, pharyngolaryngeal pain, and jitteriness. Overall, SYMBICORT was generally well-tolerated.
Asthma is a chronic inflammatory disease of the airways characterized by excessive sensitivity of the lungs, or increased reaction 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 to treat adults with asthma and guidelines on how to help use them, 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 4 year period. Additionally, asthma patients who have experienced an asthma attack are twice as likely to experience additional exacerbations as other patients. 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, such as formoterol, 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 (see WARNINGS in full Prescribing Information).
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.
Adrenal insufficiency may occur when patients have been transferred from systemically active corticosteroids to inhaled corticosteroids. SYMBICORT should not be used for transferring patients from systemic corticosteroid therapy.
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 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 at www.SYMBICORT-US.com.
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?, PULMICORT RESPULES?, PULMICORT TURBUHALER?, and RHINOCORT AQUA?, AstraZeneca is providing patients with effective treatment options to help manage their conditions.