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FDA Approves Pharmaxis' ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
Date:10/6/2010

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) <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 (rate 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.

About Pharmaxis

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 Securit
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