, Nov. 10, 2010
/PRNewswire/ -- Pharmaxis, a global specialty pharmaceutical company focused on therapeutic products for respiratory and immune disorders, will present ARIDOL (mannitol inhalation powder) Bronchial Challenge Test Kit, at the 2010 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI), November 11-16
in Phoenix, AZ.
Approved by the U.S. Food and Drug Administration (FDA) on October 5, 2010, ARIDOL is the first new bronchial challenge test in more than two decades. It is used for the assessment of bronchial hyperresponsiveness in patients six years of age and older who do not have clinically apparent asthma. The easy-to-administer, single-use test, which delivers dry powder mannitol to the patient through a hand-held inhaler, can be conducted in a variety of healthcare settings including physician offices and pulmonary function labs. ACAAI meeting attendees can preview ARIDOL and see a demonstration of how it works at the Pharmaxis booth #s1124 and 1126.
ARIDOL is an easy-to-administer, accurate and reproducible bronchial challenge test that requires minimal preparation and administration time. A positive response is indicated when there is a 15% reduction in lung function from baseline.
ARIDOL has been found effective and recognized as generally safe in two Phase III global clinical trials. It is widely recognized by experts as a significant addition to the tools available to help in an overall clinical assessment of asthma. ARIDOL should not be used as a stand-alone tool to assess asthma, but as part of a physician's overall assessment of asthma.
Other Bronchial Challenge Tests
Unlike other bronchial challenge tests, ARIDOL is a single-use test that requires less preparation time, eliminates reconstitution and use of a nebulizer to administer, with little clean-up and sterilization. A positive ARIDOL test is complete in approximately 20 minutes, compared to an average of 44 minutes for a methacholine test.(1) A methacholine test requires a nebulizer to administer, a 20% reduction in FEV1 and a designated testing room with ventilation.(2) Tests that use exercise to assess bronchial hyperresponsiveness require special equipment and conditions, and may not be appropriate for patients with physical limitations.
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 test result. A positive response is indicated when there is a 15% reduction in (FEV1) from baseline or a 10% incremental reduction in (FEV1) between successive doses. The lower the dose required to cause bronchoconstriction, the more severe the bronchial hyperresponsiveness.
The safety and efficacy of ARIDOL as a bronchial challenge test were demonstrated in two global Phase III clinical trials, which assessed the effectiveness of the ARIDOL bronchial challenge test in patients with symptoms suggestive of asthma and in clinically diagnosed asthmatic patients six years of age and older. ARIDOL demonstrated consistent effectiveness across both study populations. 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.
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., FEV1 <1-1.5 liters or <70% of the predicted values).
ARIDOL is contraindicated in patients with known hypersensitivity to mannitol, the active ingredient in ARIDOL, or to the gelatin used to make the capsules. The product is also contraindicated for patients with medical conditions that may be compromised by induced bronchospasm or repeated spirometry maneuvers.
Bronchial challenge testing with ARIDOL should not be performed in children less than 6 years of age due to their inability to provide reliable spirometric measurements.
Use with caution in patients with conditions that may increase sensitivity to the bronchoconstricting or other potential effects of ARIDOL such as: severe cough, ventilatory impairment, unstable angina, or active upper or lower respiratory tract infection that may worsen with use of a bronchial irritant.
The most common adverse reactions (greater than or equal to 1%) were headache, pharyngolaryngeal pain, throat irritation, nausea, cough, rhinorrhea, dyspnea, chest discomfort, wheezing, retching and dizziness. No formal drug-drug interaction studies have been conducted with ARIDOL.
Pharmaxis is a global specialty pharmaceutical company involved in the research, development and commercialization of therapeutic products for chronic respiratory and immune disorders. The company's development pipeline includes Bronchitol 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 is listed on the Australian Securities Exchange (symbol PXS). The company is headquartered in Sydney, Australia with regional offices in the U.S. (Exton, PA), Europe and Asia Pacific. For more information about Pharmaxis, visit www.pharmaxis.com.
(1) Anderson SD, Charlton B, Weiler JM, et al. Comparison of mannitol and methacholine to predict exercise-induced bronchoconstriction and a clinical diagnosis of asthma. Respir Res. 2009;10:4.
(2) Provocholine® (methacholine chloride powder for inhalation) [prescribing information]. Methapharm Inc. January 2008.
Please call Daina Cardillo at 203-762-8833 for full prescribing information.