Navigation Links
Pharmaxis Announces NDA Filing for Aridol(TM) (Mannitol Bronchial Challenge Test)
Date:3/3/2009

A Potential New Tool in the Diagnosis and Assessment of Asthma

EXTON, Pa., March 3 /PRNewswire/ -- Pharmaxis, Inc., a wholly owned subsidiary of Pharmaxis Ltd (ASX: PXS, Nasdaq: PXSL), 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(TM) (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.

About Pharmaxis

Pharmaxis is an emerging respiratory specialty pharmaceutical company that researches, develops and commercializes new therapies for undertreated respiratory diseases. Its development pipeline includes: Aridol(TM) (mannitol bronchial challenge test) a tool to diagnose and assess asthma; Bronchitol(TM) (mannitol) for Cystic Fibrosis, bronchiectasis, and chronic obstructive pulmonary disease (COPD); PXS25 for the treatment of lung fibrosis; and PXS4159 for asthma. Founded in 1998, Pharmaxis Ltd is headquartered in Frenchs Forest, Australia with U.S. headquarters in Exton, PA. For more information, visit www.pharmaxis.com.


'/>"/>
SOURCE Pharmaxis, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Pharmaxis to Expand Manufacturing Capacity
2. FamilyLink.com, Inc. Announces New Lead Developer
3. Providence Service Corporation Announces That Avalon Correctional Services Has Abandoned Its Consent Solicitation
4. American Psychiatric Foundation Announces Recipients of Helping Hands Grants
5. Acuo Technologies(R) Announces Another Record Sales and Implementation Growth
6. CorNova Announces Addition of Andrew T. Jay, D.M.D., M.B.A., to its Board of Directors
7. Marketing Technology Solutions Announces Strong 2008 Growth and Web Site Enhancements for QualityHealth.com
8. Genoptix Announces Participation at Barclays Capital Global Healthcare Conference
9. Marinus Pharmaceuticals, Inc. Announces Positive Results of its Phase 2 Clinical Trial of Ganaxolone as Adjunctive Therapy in Adults With Partial Onset Seizures
10. Osteotech Announces Fourth Quarter and Full Year 2008 Earnings Release and Conference Call; Company to Release Financial Results on Wednesday, March 4, 2009 and Host Call on Thursday, March 5, 2009
11. WellPoint Announces Appearances at Upcoming Conferences
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... Milford, NJ (PRWEB) , ... October 13, 2017 , ... ... weekend at scenic Alexandria Park in Milford, NJ. This free event, sponsored by ... and physical activity. The fun run is geared towards children of all ages; ...
(Date:10/13/2017)... ... 2017 , ... “America On The Brink”: the Christian history of the United ... the creation of published author, William Nowers. Captain Nowers and his wife, Millie, ... spent thirty years in the Navy. Following his career as a naval aviator ...
(Date:10/12/2017)... ... ... IsoComforter, Inc. ( https://isocomforter.com ), one of the Nation’s premier ... of the shoulder pad. The shoulder pad provides optimal support and full contact ... using cold therapy. By utilizing ice and water that is circulated from an insulated ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader in healthcare ... Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during ... , The annual award competition recognizes editorial and design excellence across a range of ...
(Date:10/12/2017)... ... 2017 , ... In the United States, single-family home owners ... New York, New Jersey, Massachusetts, Texas, Virginia, Connecticut, and California—the average is $7,000 ... property-tax rates, which contributes to the relatively lower cost of living in places ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)... Calif. , Oct. 11, 2017  BioPharmX Corporation ... scientific team that developed an innovative way to use ... of the delivery of new drugs. ... Fall Clinical Dermatology Conference will show how researchers from ... Hospital, Harvard Medical School used a suite of imaging ...
(Date:10/10/2017)... , Oct. 10, 2017  NDS received FDA 510(k) clearance in ... medical-grade battery-powered display stand specifically designed for endoscopy environments. An innovative ... into a clinical solution to support the improvement of patient outcomes, ... Design ... Solution ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
Breaking Medicine Technology: