Bronchitol® (mannitol inhalation powder) is now available as an add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis.

The approval of Bronchitol was based on results from 3 randomized, double-blind, controlled phase 3 trials in patients with cystic fibrosis. Treatment with Bronchitol significantly improved lung function (FEV1) when compared with control. The most common adverse reactions associated with therapy included cough, hemoptysis, oropharyngeal pain, vomiting, bacteria in sputum, pyrexia, and arthralgia.

Bronchitol should only be used by adults who have passed the Bronchitol Tolerance Test (BTT), which identifies patients who are hyperresponsive to Bronchitol through a series of monitored inhalations of increasing doses. The test must be performed under the supervision of a health care practitioner who is able to manage acute bronchospasm. For patients who have passed the BTT, treatment is administered by oral inhalation twice a day, once in the morning and once in the evening. A short-acting bronchodilator should be administered by oral inhalation before every dose of Bronchitol.

Bronchitol is supplied as 40mg of mannitol per capsule in 10-, 140-, and 560-count cartons with inhalers. The Bronchitol inhaler should be discarded and replaced after 7 days of use.


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Commenting on the product launch, Jon Zwinski, General Manager and Chief Executive Officer of Chiesi USA. “We are excited to bring the first dry powder inhaled mucoactive agent to the US for adults with CF, delivered by a portable device that doesn’t require routine maintenance or cleaning.”

Reference

1.      Chiesi USA, Inc. announces commercial availability of Bronchitol® (mannitol) inhalation powder for improvement in pulmonary function in adult patients with cystic fibrosis. [press release]. Cary NC: Chiesi USA Inc; March 17, 2021.

2.      Bronchitol [prescribing information]. Cary, NC: Chiesi USA, Inc; 2020.