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news.Aradigm has received FDA clearance for Phase III clinical trial of Pulmaquin (dual release ciprofloxacin for inhalation) in non-cystic fibrosis bronchiectasis (BE) patients.
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Pulmaquin is a once-a-day novel inhaled formulation consisting of a proprietary mixture of unencapsulated ciprofloxacin and ciprofloxacin encapsulated in liposomes.
The formulation allows for both immediate and sustained release of the drug within the lung.
Aradigm president and chief executive officer Igor Gonda said the once daily inhaled antibiotic has the potential to become an important chronic treatment for the management of bronchiectasis patients.
"Pulmaquin has been tested extensively in preclinical tests as well as in the ORBIT-2 Phase 2b bronchiectasis study which found excellent antimicrobial activity coupled with good safety and tolerability," Gonda added.