Pharmaxis has received the US Food and Drug Administration (FDA) approval to market Aridol (mannitol inhalation powder) bronchial challenge test kit.
Aridol is a single-use, indirect test that is easy-to-administer, requires minimal preparation time and only a 15% reduction in lung function from baseline, Pharmaxis said.
Aridol is used for the assessment of bronchial hyperresponsiveness in patients six years of age and older who do not have clinically apparent asthma and many clinicians consider an indirect bronchial challenge test to be preferable to direct challenge tests.
Aridol should not be used as a standalone tool to assess asthma, but as part of a physician’s overall assessment of asthma.
Pharmaxis president Stephen Beckman said that their new bronchial challenge test brings patients and the medical community an effective, accurate, reproducible test that requires minimal preparation and administration time, and can be conducted in a pulmonary function lab or physician’s office.
“Aridol has been proven safe and effective in two Phase III clinical trials, and is widely recognised as a significant addition to the tools available to help in an overall assessment of asthma. We anticipate commercial availability of Aridol in the first quarter of next year,” Beckman said.