Pharmaxis receives Bronchitol complete response

Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) received a complete response letter from FDA for an NDA for Bronchitol mannitol to improve pulmonary function in cystic fibrosis (CF) patients six years of age and older. According to the company, FDA recommended Pharmaxis conduct an additional clinical trial for Bronchitol because submitted data from two Phase III trials for the product did not provide a favorable risk-benefit balance. In January, FDA's Pulmonary-Allergy Drugs Advisory Committee voted unanimously against approval of Bronchitol (see BioCentury Extra, Jan. 30). ...