No serious AEs after 12 months of Bronchitol

US drugmaker Pharmaxis says that the Phase III clinical trial evaluating the long-term safety of Bronchitol, a dry-powder mannitol formulation, in subjects with bronchiectasis has concluded with no serious adverse events attributed to the drug following 12 months of treatment.

A total of 123 subjects started treatment with 320mg Bronchitol twice per day and 99 subjects completed the full 12 months of the trial. Of the 24 withdrawals, only seven were a result of adverse events (three related to lung infections and two to cough).

The most common adverse events attributed to treatment were cough in 9% of the subjects and sore throat in 5%. Other reported adverse events related to treatment were infrequent, mild and in most cases a consequence of the underlying disease. Company chief executive Alan Robertson said that Pharmaxis intends to file a marketing application in Australia for Bronchitol "as soon as possible."