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FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis
Date:3/11/2010

ge of survival for patients in the US was 37.4 years according to data compiled by the Cystic Fibrosis Foundation(2). The major consequences of the disease are pancreatic insufficiency and reduced lung function. Lung disease accounts for about 90 percent of the mortality associated with CF(3). Patients with cystic fibrosis have dehydrated, thickened respiratory secretions that are difficult to clear and provide an attractive environment for bacteria, thus increasing the risk of infection and inflammation(2).

Pulmonary infections in CF patients are a chronic problem and represent the leading cause of exacerbations and mortality(3,4). P. aeruginosa is the leading pathogen in CF patients(5). The thick mucus in the lungs is ideally suited to bacteria, and individuals with CF are colonized and infected by bacteria from an early age; about 20 percent of children under 1 year of age and 80 percent of adult patients with CF have P. aeruginosa present in their sputum(6). Chronic infection with P. aeruginosa is associated with an accelerated decline in pulmonary function, more frequent exacerbations, and increased mortality in patients with CF(3, 7, 8).

Clinical Trials with Ciprofloxacin DPI


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SOURCE Bayer HealthCare Pharmaceuticals
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