Brochitol impresses in Ph III bronchiectasis trial

Australian drugmaker Pharmaxis says that its developmental bronchiectasis treatment Bronchitol (mannitol) has met two primary efficacy endpoints, improving both patient quality of life and mucus clearance, in a Phase III trial. Participants were provided with either Bronchitol, or placebo, for an initial 12-week period, before being switched to Bronchitol in a year-long treatment regimen designed to evaluate the drug's long-term effects.

The study, which enrolled 362 patients suffering from the lung condition, showed that treatment improved quality of life, as examined using a self-assessment questionnaire. The data also demonstrated that Bronchitol improved mucus clearance rates in treated subjects, compared with those who received placebo. Pharmaxis reported that no serious adverse events had been observed during the program, adding that there was little difference in the rate of adverse reactions between the control and drug-treated groups.

Recently, Pharmaxis requested a Special Protocol Assessment clearance from the US Food and Drug Administration to conduct a Phase III assessment of Bronchitol.