Pharmaxis Completes Recruitment of Pivotol Bronchitol Cystic Fibrosis Clinical Trial for US Market
Release Date: 15/07/2016 8:30am
Pharmaceutical research company Pharmaxis today announced it has completed recruitment of its international clinical trial evaluating Bronchitol® (mannitol) in adults with cystic fibrosis. The results of the trial (CF303) are expected to be reported in the second quarter of 2017.
The Phase 3 trial is being conducted in accordance with the requirements of the US Food and Drug Administration (FDA) to gain approval for Bronchitol to treat cystic fibrosis (CF) in the United States in adult patients. Subject to a positive trial outcome, the Company will submit a response to the FDA and a decision on approval can be expected in 2018.
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