Bronchiectasis Trials Should Be Longer, Focus On Exacerbation Frequency
Bayer's endpoint for Phase III trials of ciprofloxacin inhaler should have focused on frequency of, rather than delay in, exacerbations, US FDA advisory committee members say; Aradigm's pending NDA in non-cystic fibrosis bronchiectasis could be impacted recommendations on endpoints, trial duration and concerns about long-term development of antibiotic resistance.
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Workshop on inhaled antibiotics serves as unusual post mortem after two public rejections at advisory committee level; agency clearly eager not to see development in field end.
Discordant results on Phase III primary endpoint in non-cystic fibrosis bronchiectasis patients troubled advisory committee members, although some suggested they would be more open to approval based upon secondary endpoint data on reduction in exacerbation frequency.
Linhaliq, an inhaled form of ciprofloxacin, appears to raise same efficacy, study design, and resistance concerns as those that resulted in a negative advisory committee review and FDA complete response for Bayer's formulation of the fluoroquinolone.