Pharmaxis Completes Treatment Phase in Pivotol Bronchitol Cystic Fibrosis Clinical Trial for US Market
Release Date: 23/02/2017 8:42am
Pharmaceutical research company Pharmaxis (ASX: PXS) today announced that the last of 423 patients has concluded treatment in its international clinical trial evaluating Bronchitol® (mannitol) for cystic fibrosis (CF). The topline results of the trial are expected to be reported in the second quarter of this year.
The Phase 3 trial known as DPM-CF-303 has been conducted in accordance with the requirements of the US Food and Drug Administration (FDA) to gain marketing approval for Bronchitol to treat adult CF patients in the United States. Subject to a positive trial outcome, a response will be submitted to the FDA and a decision on approval can be expected in the second half of 2018.