The US Food and Drug Administration (FDA) has granted orphan drug designation for Bayer HealthCare’s investigational Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) to treat patients with non-cystic fibrosis bronchiectasis (NCFB).
NCFB patients suffer from frequent severe acute pulmonary bacterial exacerbations that lead to further lung damage and inflammation.
Bayer HealthCare member of the executive committee and head of global development Jörg Möller said as frequent and severe exacerbations are common in patients with NCFB, there is a significant unmet medical need for long-term treatment options.
"We are pleased to receive the orphan drug designation from the FDA for Ciprofloxacin DPI," Möller said.
"If the Phase III trial programme confirms our belief that Ciprofloxacin DPI can become an effective and safe treatment for this condition, patients may benefit from significantly fewer exacerbations and an improved quality of life."
The company is developing Ciprofloxacin DPI for NCFB patients with respiratory bacterial pathogens, including Pseudomonas aeruginosa, to reduce the frequency of acute exacerbations.
The drug includes Ciprofloxacin formulated into dry powder for inhalation using Novartis‘s PulmoSphere technology combined with its pocket-sized T-326 inhaler.
PulmoSphere technology is an emulsion-based spray drying process that produces light, porous particles for deep delivery into the lung.
The technology results in Ciprofloxacin DPI particles of less than 5µ in aerodynamic diameter to provide efficient and targeted antibacterial therapy to the lung.
Clinical efficacy and safety of chronic intermittent Ciprofloxacin DPI therapy in NCFB patients is currently being studied in a global Phase III trial programme called RESPIRE, which is aimed at showing superiority of the drug compared with placebo.
The RESPIRE programme includes two multinational, randomised, placebo-controlled, double-blind, multi-centre trials that investigate the clinical efficacy and safety of chronic intermittent Ciprofloxacin DPI therapy in NCFB.
The company said that NCFB is a chronic respiratory disease, with an estimated 50%-80% of cases idiopathic.