US FDA reviewers: Efficacy data analyses for Pharmaxis CF drug 'problematic'
This article was originally published in Scrip
US FDA drug reviewers said the efficacy data for Pharmaxis' experimental cystic fibrosis (CF) medication Bronchitol, a formulation of mannitol administered as a dry powder in a hand?held inhaler, are "problematic," with frequent and treatment-related early discontinuations in the firm's two studies resulting in systematically missing measurements of lung function.
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