| Injectable Formulation of Zileuton (Zileuton Injection)
We are developing an injectable formulation of zileuton for adjunctive use in emergency room or urgent care settings for patients experiencing acute exacerbations of asthma. We completed a Phase I/II clinical trial of the injectable formulation of zileuton in August 2006. The trial was designed to evaluate safety, tolerability and pharmacokinetics of zileuton injection in patients with asthma. We plan to initiate a Phase II clinical trial in the second half of 2007 that will be focused on determining efficacy and identifying the optimal dose to be tested in Phase III clinical trials
Therapeutic Opportunity
According to the American Lung Association, in 2004, approximately 1.8 million hospital emergency room visits in the United States involved asthma attacks and approximately 497,000 hospital discharges were attributable to asthma. Currently, most patients suffering severe asthma attacks are treated with bronchodilators inhaled via a nebulizer, typically for 20 minutes or more. Nebulizers attempt to restore airway function by delivering the bronchodilatory drug directly into the lungs. However, the patient’s ability to get the drug into his or her lungs may be impaired by his or her inability to breathe efficiently due to the severe asthma attack. Clinical data demonstrate that zileuton exhibits its maximum effect on lung function when the blood drug concentration reaches its peak level and that an effect may be achieved after a single oral dose of zileuton. We believe that an injectable formulation of zileuton that would deliver zileuton directly to the bloodstream would have a rapid onset of action, reaching peak blood concentration within minutes of the injection. We believe that this rapid delivery of the drug to the patient’s bloodstream may lead to more rapid symptom improvements, and potentially reduce the number of hospital admissions of patients arriving in the emergency room suffering from a severe asthma attack.
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