Pharmaxis Begins Trial of Bronchitol in CF
Pharmaxis has announced the launch of a Phase III trial of Bronchitol that is being conducted initially in 40 hospitals across Australia, the UK and Ireland. The study is the final clinical step before Pharmaxis plans to file for approval to market the drug for treating cystic fibrosis (CF) in the European Union, Australia and elsewhere.
Pharmaxis is developing Bronchitol as a treatment to improve mucus clearance in the lungs of patients with CF, bronchiectasis and chronic obstructive pulmonary diseases. Bronchitol is a patented, inhalable dry powder formulation of mannitol that can be administered by a hand-held, pocket-sized device. The FDA has granted Bronchitol fast-track status, and it is designated as an orphan drug in the U.S. and Europe.
The Phase III trial design has been constructed following consultation with the European and Australian regulatory agencies and will assess the effectiveness and safety of Bronchitol in treating CF.
The trial is designed to include a 26-week efficacy treatment period, followed by a 26-week safety extension period. The efficacy component of the trial is a randomized, double-blind investigation of Bronchitol twice daily in approximately 250 patients with CF. The trial is enrolling CF patients ages 6 and older. Participants will be assessed for improvements in lung function, infectious episodes and quality of life.