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Bayer's ciprofloxacin dry powder inhaler receives orphan drug designation for cystic fibrosis
Thursday, March 11 2010 | Comments
What's This?
The Food and Drug Administration granted an orphan drug designation to Bayer Schering Pharma AG's ciprofloxacin dry powder inhaler (DPI) for the management of chronic pulmonary infections resulting from Pseudomonas aeruginosa in patients with cystic fibrosis (CF).The product is being studied in Phase II trials to assess its safety and potential to improve lung function, as measured by forced expiratory volume in one second, in this patient population.
In Phase I studies, ciprofloxacin DPI was shown to reach high concentrations in the lung with very low systemic exposure following single- and multiple-dose administration. It also appeared to be well-tolerated, "without clinically relevant drug treatment-related adverse effects," according to Bayer.
The inhaler is also being studied in a Phase II trial in patients with non-CF bronchiectasis.
The product combines ciprofloxacin dry powder that is formulated using Novartis AG's proprietary PulmoSphere technology and a delivery inhaler.
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