Pharmaxis Agrees Key Cystic Fibrosis Trial Parameters with FDA on Bronchitol
Release Date: 21/05/2013 12:00am
Pharmaceutical company Pharmaxis (ASX: PXS) today announced it had concluded a productive end of review meeting with the US Food and Drug Administration (FDA) which has provided the Company with a clear outline of the clinical trial required to gain approval for Bronchitol® (mannitol) to treat cystic fibrosis (CF) in the United States.
The Type A meeting discussed the remaining clinical work required to show substantial evidence of efficacy in patients with cystic fibrosis. The FDA and Pharmaxis agreed that the clearest and most expeditious regulatory path forward is to conduct a further single pivotal trial in adults aged 18 years and over. It was also agreed that the trial should have a very similar design to the two large scale clinical trials already undertaken by Pharmaxis (CF 301 and CF 302). It will be of six months duration with improvement in lung function as measured by a change in Forced Expiratory Volume in 1 second (FEV1) as its primary endpoint.
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