Pharmaxis progresses Bronchitol
Tuesday, 05 May, 2009
Pharmaxis has reported positive results from its Phase III trial of lead candidate Bronchitol in cystic fibrosis patients.
Bronchitol, a dry-powder mannitol formulation that hydrates the airway surface of the lungs and helps clear mucus build-up, was found to improve lung function significantly when administered twice a day for six months.
It also improved lung function when used in conjunction with dornase alfa (Pulmozyme), the most commonly used cystic fibrosis drug.
The trial was conducted in 40 centres in Europe, Australia and New Zealand in consultation with the European Medicines Agency. Pharmaxis hopes to gain marketing authorization in Europe and will file an application later this year.
It has already received orphan drug designation and fast track status from the US FDA.
The company said it would present the study’s findings at a European scientific meeting in June and an American scientific meeting in October.
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