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Bronchitol
Overview
Pharmaxis' key product in development, Bronchitol, is a drug designed to reduce the amount of mucus build-up in the lungs of patients suffering from chronic respiratory conditions.
Pharmaxis is developing Bronchitol for diseases including cystic fibrosis, bronchiectasis and chronic bronchitis. Bronchitol is a proprietary formulation of mannitol administered as a dry powder in a convenient hand-held inhaler. Bronchitol hydrates the lungs, helps restore normal lung clearance, and allows patients to clear mucus more effectively. Clinical studies have shown Bronchitol to be safe, effective, and well tolerated in treating patients with both cystic fibrosis and bronchiectasis.
The results from a major Phase 3 trial with Bronchitol in patients with cystic fibrosis demonstrated that Bronchitol is a safe and effective treatment. There have been limited therapeutic advances in the past decade to help clear congested lungs for patients with cystic fibrosis, a condition which affects 75,000 people worldwide.Bronchitol has been awarded fast-track status in the U.S., and orphan drug designation in both the US and EU.
The product is also being developed for use in bronchiectasis, a disease affecting 600,000 globally. Bronchitol will be the first targeted medication for this condition in over 20 years. A Phase 3 clinical trial of Bronchitol in people with bronchiectasis found that it delivered a highly significant improvement in users' quality of life. A second Phase 3 clinical trial is in progress around the world and is studying the effects of Bronchitol on reducing the infectious episodes, antibiotic use and hospitalization stays for patients with bronchiectasis.
Recent Bronchitol Milestones - Completion of second Phase 3 trial for Bronchitol treatment of cystic fibrosis
- Application filed to EMeA to market Bronchitol in Europe for treatment of cystic fibrosis
- Screening commenced for Phase 3 trial for Bronchitol treatment of bronchiectasis
- A pivotal Phase 3 trial with Bronchitol in patients with cystic fibrosis demonstrated that Bronchitol is safe and effective for improving lung function.
- An oral presentation of the cystic fibrosis phase 3 trial results at the European annual cystic fibrosis scientific meeting
Upcoming Bronchitol Events - European marketing approval for Bronchitol to treat cystic fibrosis
- United States FDA application for Bronchitol to treat cystic fibrosis
- Presentation of CF302 data at North American Cystic Fibrosis Conference