Pharmaxis, Inc., a wholly owned subsidiary of Pharmaxis Ltd , an emerging respiratory specialty pharmaceutical company, announced today that it has filed a New Drug Application (NDA), electronically, with the U.S. Food and Drug Administration (FDA) for Aridol (mannitol bronchial challenge test).
Bronchial challenge tests are designed to assess bronchial hyperresponsiveness, an important marker in the diagnosis and assessment of asthma.
"A definitive asthma diagnosis and effective monitoring and management of the disease have been long-standing challenges for doctors and patients with asthma," said William Storms, MD, Allergist, Colorado Springs, CO. "The primary method of diagnosis -- a detailed history and physical examination of the patient, has remained relatively unchanged for many years and is largely absent of any routine test to confirm the diagnosis."
Brett Charlton MBBS, PhD, Medical Director, Pharmaxis Ltd, added, "Aridol is designed to measure bronchial hyperresponsiveness that corresponds with airway inflammation, an important underlying component of asthma."
Aridol will be a standardized test kit containing proprietary dry-powder mannitol (a naturally occurring sugar alcohol), prepared for delivery to the lungs using a proprietary hand-held inhaler. The goal of Aridol is to provide physicians and health care professionals with an objective measure of active airway inflammation through an easy-to-use, single-use test for asthma care and assessment in a variety of healthcare settings.