US FDA fast-tracks Parmaxis' Bronchitol

Australian pharmaceutical company Pharmaxis has been granted US Food and Drug Administration fast-track status for its cystic fibrosis product Bronchitol (mannitol).

Phase II studies showed Bronchitol significantly improves lung function and well-being in patients with cystic fibrosis which affects approximately 75,000 people in the developed world, including 33,000 US patients and 2,500 Australians - a fifth of whom are children under five years old.

There have been no treatment advances in over a decade and no products have previously been approved to improve lung hydration. The FDA recognizes the positive clinical data for Bronchitol in treating the lethally inherited condition of cystic fibrosis.