Aradigm requests orphan drug status for inhaled liposomal ciprofloxacin for cystic fibrosis

By E. Janene Geiss

Philadelphia, Jan. 5 - Aradigm Corp. announced Thursday that it has filed a request for orphan drug designation with the U.S. Food and Drug Administration for its liposomal ciprofloxacin product for the management of cystic fibrosis.

The company's clinical program will investigate the pulmonary delivery of the novel formulation of this widely used anti-infective for its local and prolonged effects in the treatment of bacterial infections in cystic fibrosis, according to a company news release.

Aradigm's liposomal formulation is designed to change the short-acting nature of ciprofloxacin so that it becomes long-acting and remains in the lung for a sufficient amount of time to treat pseudomonas infections commonly found in patients with the disease, officials said.

Orphan drug status may be granted to drugs that treat rare life-threatening diseases that affect less than 200,000 people in the United States.

Such designation provides a company with seven years of marketing exclusivity for a selected drug approved by the FDA, along with regulatory assistance, reduced filing fees and possible tax credits.

Aradigm said it recently hosted a meeting of leading cystic fibrosis medical experts to discuss the use of liposomal ciprofloxacin in this patient population. The experts expressed an opinion that this product could meet an important unmet medical need as an additional antibiotic to treat cystic fibrosis-related respiratory infections.

"We believe that liposomal ciprofloxacin could play an important role in improving the quality of life of patients with cystic fibrosis," said Babatunde Otulana, vice president of clinical and regulatory affairs at Aradigm, said in the release.

Aradigm is a Hayward, Calif., biopharmaceutical company that combines non-invasive delivery systems with novel formulations to create products that enable patients to comfortably self-administer biopharmaceuticals and small molecule drugs.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.