Chiesi USA announces commercial availability of Bronchitol in USA

The US subsidiary of family-owned Italian drugmaker Chiesi Farmaceutici today announced the launch of Bronchitol (mannitol) inhalation powder, an add-on maintenance therapy to improve pulmonary function in cystic fibrosis (CF) patients 18 years of age and older.

Bronchitol is the first and only dry powder inhaled mucoactive agent providing a compact, portable option for patients that was approved in this formulation by the US Food and Drug Administration in November last year.

Additionally, data from the global Phase III study evaluating the efficacy and safety of inhaled dry powder mannitol in adults with CF has been published online in the Journal of Cystic Fibrosis. In the multicenter, double-blind, randomized, parallel-group, controlled study of 423 adults with CF, subjects received either mannitol 400mg or mannitol 50mg (control), twice-daily via dry powder inhaler for 26 weeks. Authors concluded that mannitol 400mg inhaled twice-daily via a dry powder inhaler statistically significantly improved lung function (FEV1) compared with control, with this improvement supported by sensitivity analyses. Most common adverse reactions (≥3%) include cough, hemoptysis, oropharyngeal pain, vomiting, bacteria sputum identified, pyrexia and arthralgia.