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This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Pharmaxis breathing easy after positive Phase III data: Pharmaxis announces positive Phase III results for its cystic fibrosis drug Bronchitol. The multi-center, international trial met its primary endpoint of improved lung function as measured by a change in Forced Expiratory Volume in 1 second (FEV1). Patients administered 400 mg twice per day for six months showed statistically significant improvement in lung function from baseline of 6.6 percent, with lung function improved at week 6 and was sustained through week 26. The trial also successfully achieved the secondary endpoint of looking at whether Bronchitol further improved lung function in patients already being treated with the most commonly used CF therapeutic - Genentech's Pulmozyme (dornase alfa); FEV1 improved 5.2 percent in patients on concurrent dornase alfa. The most common adverse event was cough, which the firm said was mild to moderate in most cases and similar between the treatment arms. Pharmaxis designed the trial in consultation with the European Medicines Agency and plans to file the application in Europe and elsewhere later this year

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