Bayer is developing Ciprofloxacin DPI for NCFB patients with respiratory bacterial pathogens, including Pseudomonas aeruginosa, to reduce the frequency of acute exacerbations.
These 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 amongst 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 program 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 drug comprises of ciprofloxacin formulated into dry powder for inhalation using Novartis’ PulmoSphere technology combined with its pocket-sized T-326 inhaler.
Currently, clinical efficacy and safety of chronic intermittent Ciprofloxacin DPI therapy in NCFB is being evaluated in a global Phase III trial program called RESPIRE.
The RESPIRE program includes two multinational, randomized, placebo-controlled, double-blind, multi-center trials that investigate the clinical efficacy and safety of chronic intermittent Ciprofloxacin DPI therapy in patients with NCFB, a chronic respiratory disease of which about 50- 80% of cases are idiopathic.