Gilead reports positive data for cystic fibrosis antibiotic

Gilead Sciences has reported positive results from a phase III study evaluating inhaled antibiotic aztreonam lysine in patients with cystic fibrosis who have pulmonary Pseudomonas aeruginosa.
In the study, a 28-day treatment course of aztreonam lysine significantly improved the time to need for inhaled or intravenous antibiotics versus placebo. All patients received an initial 28 days of treatment with tobramycin inhalation solution prior to receiving study drug. Aztreonam lysine for inhalation was well tolerated and patients also experienced significant improvements in pulmonary function and respiratory symptoms.

The study was designed to assess the safety and efficacy of a 28-day treatment course with aztreonam lysine for inhalation following a 28-day treatment course of tobramycin inhalation solution in people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa.

"Pulmonary pseudomonal infection remains the leading cause of sickness and death in people with cystic fibrosis," said Karen McCoy, chief of the Division of Pediatric Pulmonology.

Gilead plans to submit a new drug application for aztreonam lysine for inhalation for the treatment of people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa to the FDA in the second half of 2007.
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