Mar 3 2009
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.
"Upon approval healthcare professionals will have an easy-to-administer bronchial challenge test improving their ability to diagnose and assess patients with asthma," said Stephen Beckman, President, Pharmaxis, Inc.
Aridol is approved for sale in Australia, major European countries and Korea. It is the first and only bronchial challenge test approved Europe-wide. Aridol has been included in various asthma, sport and occupational screening guidelines including; the GINA Report of Global Strategy for Asthma Management and Prevention, the U.S. Asthma Management Guidelines, the International Olympic Committee independent medical commission's guidelines for beta-2 agonist use in the 2008 Summer Olympics in Beijing, China, guidelines from the World Anti-Doping Agency, and those issued by other sports-governing bodies to ensure appropriate assessment and management of elite athletes who are asthmatic.