Bronchitol Reduces Risk of Exacerbations - Additional Data
Release Date: 08/06/2012 12:00am
Pharmaceutical company Pharmaxis (ASX: PXS) today presented a new analysis of its two Phase 3 clinical studies of Bronchitol® showing positive trends in reducing exacerbations in all age sub groups of cystic fibrosis patients.
The analysis which focuses on adult patients, has been presented at the European Cystic Fibrosis Meeting taking place in Ireland. Its release coincides with the commercial launch of Bronchitol in the UK and Germany following the approval by the European Medicines Agency of Bronchitol earlier this year for the treatment of cystic fibrosis in adults as an add-on therapy to best standard of care.
The two phase 3 studies contained 341 adult patients and their results were broadly consistent with those from the overall population of 600 patients which included adolescents and children.
• Adult patients who showed an increase in lung function on Bronchitol had 59% fewer exacerbations than patients who showed no improvement (p=0.03).
• Exacerbation incidence was reduced by 29% in the overall population (p=0.039) and there were consistent improvements in all age groups with a 24% reduction in adults (NS).
• Sputum weight in adult patients was significantly increased at both 6 and 14 weeks
• Lung function in adults showed significant improvements over the 6 months of the study and were sustained out to 12 months.
• For adults, there was no increase in treatment burden after taking Bronchitol for 6 months.
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