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Ciprofloxacin inhalant powder given orphan drug status
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The FDA has granted orphan drug designation for Bayer HealthCare’s investigational ciprofloxacin dry inhalation powder for the treatment of non-cystic fibrosis bronchiectasis, according to a news release from the drug company.
The antibiotic treatment is currently being tested in a phase 3 clinical trial to reduce the frequency of acute exacerbations in non-cystic fibrosis bronchiectasis (NCFB) patients with bacterial respiratory infections.
According to researchers, more than half of NCFB cases are idiopathic. Bronchiectasis is characterized by the distortion of the airways, resulting in chronic cough, sputum production and recurrent bacterial infections. The persistence of infection and inflammation leads to the acquisition of new infections and the destruction of the bronchial walls. Most patients with bronchiectasis are colonized with Haemophilus influenza (29%-70%) and Pseudomonas aeruginosa (12%-31%), which has been associated with the most severe disease. The most common reported causes of NCFB are categorized as post-infectious.
The investigational treatment was given orphan drug status because NCFB is a rare condition, with an estimated 110,000 people currently being treated for the disease in the United States.