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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

In Phase I studies with ciprofloxacin DPI, including those in pediatric(9) and adult CF patients, ciprofloxacin has been shown to reach high concentrations in the lung with very low systemic exposure following single and multiple dose administration (10, 11, 12).  Adverse events reported in the Phase I studies included transient bitter taste after inhalation, a report of transient reduction of FEV1 that resolved without intervention, and one report of bronchospasm related to study drug(13).  A multinational Phase II study evaluating safety and efficacy in CF patients is ongoing with the primary end point of improvement in lung function, measured by FEV1.  An additional clinical study of ciprofloxacin DPI not related to the orphan drug designation for CF is ongoing.  This study in patients with non-CF bronchiectasis is evaluating the safety and efficacy of ciprofloxacin DPI with respect to overall bacterial load and clinical outcomes.  

About Orphan Drug Designation in the United States

Under legislation passed by the U.S. Congress in 1983, the Orphan Drugs Act provides incentives to sponsors to develop products for rare diseases.  The first sponsor who obtains marketing approval for a designated orphan drug or biological product is granted US market exclusivity for a seven-year period.  Exclusivity begins on the date that the marketing application is approved by the
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SOURCE Bayer HealthCare Pharmaceuticals
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