Acute exacerbations of asthma are long-lasting asthma episodes in which asthma symptoms are not responsive to initial bronchodilator or corticosteroid therapy. Status asthmaticus, a severe asthma episode, is an emergency situation that can lead to hospital admission and death. Beta-agonist agents are the mainstays of acute treatment for these types of asthma attacks. The inhaled route is generally more effective; however, in some severe cases, there is so little airflow that inhalation does not work. In these cases, intravenous or subcutaneous administration may be used.
A COPD exacerbation is a sustained worsening of the patient’s condition, beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD. Exacerbations are associated with a significant increase in mortality, hospitalization and healthcare utilization.
Data from the National Center for Health Statistics show that in the U.S., annual visits to emergency departments for asthma are approximately 1.75 million, and there were approximately 456,000 hospitalizations and approximately 3,447 deaths due to asthma in 2007 According to the National Heart, Lung and Blood Institute, the direct costs associated with hospital care due to asthma were estimated at $5.5 billion in the U.S. in 2010. Accordingly, we believe that there remains an unmet medical need for a safe and effective treatment for acute exacerbations of asthma that could prevent some of these hospitalizations.
The number of deaths due to COPD in the U.S. has more than doubled since 1980 to more than 124,000, according to a 2011 report on COPD from the American Lung Association, which used data from the Centers for Disease Control and Prevention. In 2010, according to the American Lung Association, the direct health care costs for COPD were $29.5 billion and indirect costs were $20.4 billion in the U.S. We believe there remains an unmet medical need for a safe and effective treatment for COPD exacerbations that could relieve bronchospasm and prevent some of these hospitalizations.