The submission seeks approval for two strengths of the drug and is based on 27 phase I, II and III trials designed to assess the efficacy and safety of the compound. The drug is currently available in 93 countries outside of the US in a dry powder inhaler device.
It is estimated that about 30 million Americans, about 10% of the US population, have been diagnosed with asthma in their lifetime, according to the American Lung Association and the National Center for Health Statistics.
Symbicort is a combination of budesonide (an inhaled corticosteroid) and formoterol (a rapid and long acting beta2-agonist). Combination therapy, adding a long-acting inhaled beta2-agonist to an inhaled corticosteroid is recommended by the National Asthma Education and Prevention Program (NAEPP) of the National Institute of Health for long-term control and prevention of symptoms in moderate and severe persistent asthma.