SYMBICORT Is Now Available In U.S.
SYMBICORT (budesonide/formoterol fumarate dihydrate) pressurized metered dose inhaler is now available in the United States for the long-term maintenance treatment of asthma in patients 12 years of age and older.
Administered twice daily, SYMBICORT is a combination of two proven asthma medications -- budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). For many patients, this combination treatment offers improved asthma control as early as day one that is sustained over 12 weeks. SYMBICORT also delivers improved lung function occurring within 15 minutes of beginning treatment. SYMBICORT does not replace fast-acting inhalers for sudden attacks.
SYMBICORT is available in two dose strengths, 80/4.5 and 160/4.5 5g of budesonide and formoterol, respectively. SYMBICORT is approved for patients whose disease is not adequately controlled on another asthma-controller medication (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with two maintenance therapies.
"With the U.S. launch of SYMBICORT, millions of asthma sufferers will have a new choice of fixed combination therapy to help achieve control of their asthma," said Chris O'Brien, MD, PhD, senior director, Medical Science, AstraZeneca.
Asthma is one of the most serious chronic diseases in the U.S. It is estimated that more than 20 million Americans suffer from the condition and, if not properly managed, asthma can be life-threatening.
"The U.S. availability of SYMBICORT holds great promise for millions of Americans that suffer from asthma," said Tony Zook, president and chief executive officer, AstraZeneca U.S. "The addition of SYMBICORT to our respiratory portfolio reinforces AstraZeneca's commitment to developing new, effective treatments, and provides patients and physicians with a new treatment option to improve and maintain lung health."
SYMBICORT was approved by the U.S. Food and Drug Administration (FDA) on July 21, 2006. The SYMBICORT submission was based on 27 Phase I, II, and III trials designed to assess the efficacy and safety of SYMBICORT in a pMDI. The approved indication is largely based on data from two pivotal double blind, placebo-controlled, 12-week trials involving 1,076 patients in the U.S., age 12 and older. These studies showed that both dosage strengths of SYMBICORT produced a greater improvement in lung function compared to the same doses of budesonide or formoterol, administered alone, or placebo. In addition, these studies demonstrated a more rapid improvement in lung function compared to budesonide and placebo. Clinically significant improvement in bronchodilatory response, or opening of the lung airways, occurred within 15 minutes of beginning treatment with SYMBICORT.
The safety profile of SYMBICORT is based on a robust U.S. development program, which evaluated safety in over 6,000 patients treated with SYMBICORT in Phase I, II and III studies that were submitted to the FDA. SYMBICORT has safety data from long-term studies up to one year and a robust cardiac safety profile.
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.
Despite the availability of many treatments for adults with asthma and guidelines on how to 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 four year period. Additionally, the study showed that asthma patients who had experienced an asthma attack were 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.
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.
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 less than or equal to 5% of patients, regardless of relationship to treatment, included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, and stomach discomfort.