Aridol mannitol regulatory update

FDA's Pulmonary-Allergy Drugs Advisory Committee supported approval of Aridol mannitol powder inhalation test from Pharmaxis to assess bronchial hyperresponsiveness (BHR) to aid in the diagnosis of patients six years of age and older with symptoms of asthma or suggestive of asthma. The panel voted 12-3, with one abstention, to support approval of Aridol for patients 18 years and older; 14-2 to support approval of Aridol in patients 12-17 years; and 11-5 in favor of Aridol in diagnosing patients 6-11 years of age. The panel's vote was based on the Phase III 305 study in which Aridol had a sensitivity of 58% vs. 53% for the Provocholine methacholine chloride challenge test, and a specificity of 63% vs. 68% for Provocholine. Although Aridol met the co-primary endpoint of confirming the test's sensitivity and specificity to detect exercise-induced bronchospasm (EIB), it failed to meet its other two co-primary endpoints, sensitivity significantly greater than 60% and specificity superior to Provocholine.

The panel agreed that while Aridol's efficacy in assessing BHR is similar to Provocholine, Aridol's ease of use and positive safety profile make it a more attractive alternative and will give physicians an additional tool for diagnosing asthma. Provocholine from Metapharm Inc. (Brantford, Ontario) is the only FDA approved product in the U.S. for the assessment of BHR. T ...