Bronchitol is approved for the treatment of cystic fibrosis to help patients clear mucus from their lungs. It is a precision spray-dried form of mannitol, delivered to the lungs by a specially designed, portable inhaler. Bronchitol works by rehydrating the airway/lung surface and promoting a productive cough.
Bronchitol® was the subject of three large scale clinical trials and is approved and marketed in Europe, Russia, Australia and the United States. The third clinical trial was the final trial required to secure approval in the United States and was primarily funded by Pharmaxis’s US partner Chiesi Farmaceutici SpA . Bronchitol received FDA approval in October 2020. Commercial launch of Bronchitol in the US is scheduled for Q2 2021.
Bronchitol is approved for marketing for the treatment of cystic fibrosis patients aged over six years in Australia and Russia and for patients aged 18 years and over throughout the European Union and the United States. In all markets, patients are required to have a tolerance test prior to being prescribed Bronchitol to ensure that they are not hyper responsive to mannitol.
Clinical trials have shown that Bronchitol helps to increase mucus clearance, and improve the lung function and the quality of life of people living with cystic fibrosis.
To visit the Bronchitol website click here