Aradigm Corp, Hayward, Calif, has received orphan drug designation from the US Food and Drug Administration (FDA) for ciprofloxacin for inhalation for the management of bronchiectasis (BE). Previously, Aradigm received orphan drug designations from the FDA for liposomal ciprofloxacin for inhalation for the management of bronchiectasis and for liposomal ciprofloxacin for the management of cystic fibrosis (CF).
Orphan drug designation is intended to encourage research and development of new therapies for diseases that affect fewer than 200,000 patients in the United States.
Currently, ciprofloxacin is prescribed to treat infections of the lung frequently experienced by CF and non-CF bronchiectasis patients. It is often preferred because of its broad-spectrum antibacterial action. The available oral and intravenous formulations of the drug are used to treat episodes of acute exacerbations of lung infections in CF patients.
Aradigm’s novel inhaled ciprofloxacin formulations are designed for once daily dosing. The dual release ciprofloxacin for inhalation (DRCFI, ARD-3150, Pulmaquin™) contains liposomally encapsulated ciprofloxacin for inhalation (CFI, ARD-3100, Lipoquin™) mixed with a solution of free ciprofloxacin for inhalation. The formulations are to be used for chronic maintenance therapy, as they are expected to achieve higher antibiotic concentration at the site of infection and relatively low systematic antibiotic concentrations to minimize side-effects.
Aradigm previously reported positive results from its 6-month phase 2b study (ORBIT-2) with Pulmaquin and other phase 2a studies of 22 CF patients and 36 bronchiectasis patients who received Lipoquin once-a-day for 2 (CF) or 4 (BE) weeks, respectively. The company announced in March 2011 that the last patient was enrolled for the ORBIT-1 study in bronchiectasis patients treated with Lipoquin or placebo for 28 days, with a 28 day follow-up period of no study drug treatment. Aradigm is also developing these formulations as a potential medication for the prevention and treatment of bioterrorism infections, such as inhaled anthrax and tularemia.
Source: Aradigm Corp