Bayer said that a similar designation has already been granted by the European Medicines Agency. Ciprofloxacin DPI is an investigational drug device combination that combines ciprofloxacin dry powder formulated using Novartis' PulmoSphere technology with a delivery inhaler.

Ciprofloxacin DPI is in Phase II development and is being studied for its safety and potential to improve lung function, as measured by the forced expiratory volume in 1 second (FEV1), in patients with CF.

In Phase I studies with ciprofloxacin DPI, including those in pediatric and adult CF patients, ciprofloxacin has been shown to reach high concentrations in the lung with low systemic exposure following single and multiple dose administration. Adverse events reported in the Phase I studies included transient bitter taste after inhalation, a report of transient reduction of FEV1 that resolved without intervention, and one report of bronchospasm related to study drug.

A multinational Phase II study evaluating safety and efficacy in CF patients is ongoing with the primary end point of improvement in lung function, measured by FEV1. An additional clinical study of ciprofloxacin DPI not related to the orphan drug designation for CF is ongoing. The study in patients with non-CF bronchiectasis is evaluating the safety and efficacy of ciprofloxacin DPI with respect to overall bacterial load and clinical outcomes.

Shannon Campbell, vice president and general manager of oncology and general medicine at Bayer HealthCare Pharmaceuticals, said: "There continue to be unmet medical needs for people with cystic fibrosis. We are pleased to receive the orphan drug designation from the FDA for ciprofloxacin DPI, which we are researching as a potential treatment option for management of pulmonary infections due to P aeruginosa in CF patients."

Source: web of PBR