EXTON, Pa., Feb. 23, 2011 /PRNewswire/ -- Pharmaxis, a global
specialty pharmaceutical company focused on therapeutic products
for chronic respiratory and immune disorders, announced today the
commercial launch of ARIDOL® (mannitol inhalation powder) Bronchial
Challenge Test Kit, the first new bronchial challenge test in more
than two decades and the company's first product launch in the U.S.
ARIDOL is used to assess bronchial hyperresponsiveness in
patients six years of age and older who do not have clinically
apparent asthma. ARIDOL should not be used as a stand alone
test to assess asthma or as a screening test for asthma, but as
part of a physician's overall assessment of asthma. ARIDOL
can be ordered directly from Pharmaxis and is available to
pulmonary function labs and physicians' offices by calling
Pharmaxis Customer Service at 1-888-416-1828.
"ARIDOL is an important advancement in bronchial challenge
testing – the first in 20 years – and a significant addition to the
tools available to help in an overall assessment of asthma," said
Stephen Beckman, President,
Pharmaxis, Inc. "We are excited to provide patients and the
medical community with an effective, accurate and reproducible test
that can be conducted in the convenience of a pulmonary function
lab or physician's office."
ARIDOL is a single-use, indirect test that is
easy-to-administer, requires minimal preparation time and a 15%
reduction in lung function from baseline for a positive test.
ARIDOL was approved by the U.S. Food and Drug Administration
(FDA) on October 5, 2010, and
demonstrated safety and efficacy in two Phase III clinical
trials.
"The ARIDOL Bronchial Challenge Test takes only about 20 minutes
to administer for a positive test and requires a 15% reduction in
FEV[1]. Previous options may take up to 40 minutes to
implement and require a 20% reduction in FEV[1]," said Bradley Chipps, MD, Capital Allergy and
Respiratory Disease Center, Sacramento, CA. "The ARIDOL Bronchial
Challenge Test offers health care professionals another tool to
help with a disease that is often hard to definitively diagnose."
"PHARMAXIS is committed to bringing our therapeutic advances for
respiratory and immune diseases to patients throughout the world.
The U.S. launch of ARIDOL highlights this commitment and our
focus on helping physicians and patients world-wide affected by
respiratory illnesses," added Mr. Beckman.
How ARIDOL Works
The ARIDOL test requires patients to inhale increasing doses of
dry powder mannitol from a simple, hand-held device, which causes
airways to narrow and contract when airway inflammation is present.
The doses are contained in capsules that are administered at
one-minute intervals until a positive response is achieved or until
all the capsules have been inhaled, indicating a negative result.
A positive response is indicated when there is a 15%
reduction in lung function from baseline compared to a 20% fall
required by a methacholine challenge test.(1) The lower the dose
required to cause bronchoconstriction, the more severe the
bronchial hyperresponsiveness.
Other Bronchial Challenge Tests
Unlike other bronchial challenge tests, ARIDOL is a single-use
test that requires less preparation time and eliminates
reconstitution, use of a nebulizer to administer, clean-up and
sterilization. A positive ARIDOL test is complete in
approximately 20 minutes, compared to an average of 45 minutes for
a methacholine test.(2) A methacholine test requires additional
equipment to administer and a designated testing room with
ventilation.(1) Tests that use exercise to assess bronchial
hyperreponsiveness require special equipment and conditions, and
may not be appropriate for patients with physical limitations.
Safety/Efficacy Profile
The safety and efficacy of ARIDOL as a bronchial challenge test
were verified in two global Phase III clinical trials, which
assessed the effectiveness of the ARIDOL bronchial challenge test
in non-asthmatic patients with symptoms suggestive of asthma and
clinically diagnosed asthmatic patients six years of age and older.
Approved for use in 19 countries, ARIDOL has been used by
more than 44,000 patients, and is marketed in Australia, major European countries and Korea.
ARIDOL is included in official international guidelines for
the clinical assessment of asthma. Organizations and guidelines
endorsing ARIDOL include: the International Olympic Committee
Medical Commission's Independent Panel on Asthma, the U.S. Asthma
Management Guidelines, the Global Initiative for Asthma (GINA)
Report on Global Strategy for Asthma Management and Prevention, the
World Anti-Doping Agency and the Australian Asthma Management
Handbook. ARIDOL is the only dry powder bronchial challenge test
approved for use in the U.S.
Indication
Mannitol, the active ingredient in ARIDOL, is a sugar alcohol
indicated for the assessment of bronchial hyperresponsiveness in
patients 6 years of age or older who do not have clinically
apparent asthma.
ARIDOL is not a stand alone test or a screening test for asthma.
Bronchial challenge testing with ARIDOL should be used only
as part of a physician's overall assessment of asthma.
Important Safety Information
WARNING: RISK OF SEVERE BRONCHOSPASM
Mannitol, the active ingredient in ARIDOL, acts as a
bronchoconstrictor and may cause severe bronchospasm.
Bronchial challenge testing with ARIDOL is for diagnostic
purposes only. Bronchial challenge testing with ARIDOL should
only be conducted by trained professionals under the supervision of
a physician familiar with all aspects of the bronchial challenge
test and the management of acute bronchospasm. Medications (such as
short acting inhaled beta-agonist) and equipment to treat severe
bronchospasm must be present in the testing area. If severe
bronchospasm occurs it should be treated immediately by
administration of a short acting inhaled beta-agonist. Because of
the potential for severe bronchoconstriction, bronchial challenge
testing with ARIDOL should not be performed in any patient with
clinically apparent asthma or very low baseline pulmonary function
tests (e.g., FEV[1]
