WILMINGTON, Del., March 11 /PRNewswire-FirstCall/ -- On March 10-11, 2010, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) -- including the Pulmonary-Allergy Drugs and the Drug Safety and Risk Management Advisory Committees -- discussed the design of post-marketing safety studies for long-acting beta-agonist (LABA)-containing products in the U.S., including SYMBICORT((R) )(budesonide/formoterol fumarate dihydrate).
“As we’ve witnessed over the past two days, there are many challenges in designing and executing a relevant, feasible and ethical post-marketing safety study that answers FDA’s question regarding LABA-containing products,” said Howard Hutchinson, M.D., Chief Medical Officer of AstraZeneca. “AstraZeneca is confident in the positive benefit-risk profile of SYMBICORT in asthma as demonstrated by extensive clinical data and patient experience, and supports ongoing scientific discussion to address any outstanding questions regarding the use of combination LABA and inhaled corticosteroid products for the treatment of asthma. We look forward to working with the FDA to execute a study design that is both scientifically robust and offers a pragmatic approach to answer critical questions regarding the appropriate use of LABAs.”
About SYMBICORT
SYMBICORT is combination therapy indicated 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 respiratory medications -- budesonide, an inhaled corticosteroid (ICS), and formoterol, a rapid and long-acting beta2-agonist (LABA). It offers patients with asthma effective symptom control with the added benefit of rapid improvement in lung function within fifteen minutes of every dose.( )
For more information about SYMBICORT, please visit www.MySYMBICORT.com.
WARNING: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related death. SYMBICORT should only be used for patients with asthma 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 in full Prescribing Information).
Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.
Caution should be exercised when considering the coadministration of SYMBICORT with long-term ketoconazole and other known potent CYP3A4 inhibitors.
Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may affect normal bone metabolism resulting in a loss of bone mineral density.
SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents.
Additional Information Specific to COPD
For patients with COPD, the approved dosage of SYMBICORT is 160/4.5 mcg, 2 inhalations twice daily.
Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids.
Please see full Prescribing Information, including boxed WARNING, and visit www.MySYMBICORT.com.
For more information about AstraZeneca in the US or our AZ&Me(TM) Prescription Savings programs, please visit: www.astrazeneca-us.com.
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