The US FDA has granted orphan drug designation to Aradigm Corporation’s dual release ciprofloxacin for inhalation (DRCFI) for the treatment of bronchiectasis. The company’s liposomal ciprofloxacin for inhalation (CFI) already has orphan drug designation from the FDA for the treatment of bronchiectasis and for cystic fibrosis.
The dual release formulation combines liposomal and free ciprofloxacin. The free ciprofloxacin acts quickly, while the liposomal drug provides sustained release.
Igor Gonda, President and CEO of Aradigm said, “We are very pleased that FDA has granted Aradigm this new orphan drug designation for bronchiectasis which provides additional incentive for our Company to develop a much needed therapeutic tool for this significant unmet medical need in respiratory medicine.”
The EMA granted orphan drug designation to inhaled liposomal ciprofloxacin for the treatment of infections in CF patients in August 2009.
Read the Aradigm press release.
