To print: Select File and then Print from your browser's menu

Title: Controlled Release Zileuton Provides Early, Sustained Improvements in Pulmonary Function: Presented at ACAAI

"Controlled Release Zileuton Provides Early, Sustained Improvements in Pulmonary Function: Presented at ACAAI"

By Corinna S. Bowser, MD PHILADELPHIA, PA -- November 15, 2006 -- While the newer twice-daily, controlled-release (CR) formulation of zileuton may not avoid the need for monitoring of liver enzymes, the treatment is well tolerated and does appear to provide early and sustained improvement in pulmonary function, researchers reported here at the 2006 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI). The results came from a pivotal randomized, placebo-controlled randomized study of zileuton CR 1200 mg twice daily in 613 patients with asthma who were not on chronic asthma treatment besides inhaled beta-agonists. An immediate-release (IR) formulation of zileuton, dosed 4 times per day, was used initially in the 1990s. The more recent twice-daily formulation was approved by the U.S. Food and Drug Administration in October 2006. "The advance is that this is BID," said investigator Stanley Fineman, MD, clinical associate professor, allergy division, department of pediatrics, Emory University School of Medicine, Atlanta, Georgia. "Patients don't like to take things 4 times a day." For their study, Dr. Fineman and colleagues randomized patients to 12 weeks of treatment in 1 of 4 arms: zileuton CR 1200 mg BID; placebo CR; zileuton IR 600 mg 4 times daily; placebo IR 4 times daily. Results showed that zileuton CR gave patients a significant improvement in both FEV[₁ and peak expiratory flow rate that was early and sustained, Dr. Fineman said in a presentation on November 12^th. At day 15, the change in FEV₁ from baseline in the zileuton CR and placebo groups was 0.23 vs 0.09 L, respectively (P less than or equal to .001). At day 85, the difference remained significant (0.39 vs 0.27, P less than or equal to .05).

Efficacy results for zileuton IR were not reported in this study.

Incidence of any adverse events was similar between groups (78.4% for zileuton CR versus 76.8% for placebo CR, respectively). The most common adverse events were headache, sinusitis, nausea, nasopharyngitis, pharyngolaryngeal pain, and exacerbation of asthma.

Alanine aminotransferase elevations at least 3 times the upper limit of normal were seen in 2.5% of patients on zileuton CR and 2.1% of those on zileuton IR, which investigators said was similar to what was seen in previous zileuton IR studies (1.9%).

This study was sponsored by Critical Therapeutics, Inc.

[Presentation title: Zileuton CR 1200 mg BID Provided Early and Sustained Improvement in Pulmonary Function Compared to Placebo in Moderate Asthmatics. Abstract P172]

Copyright © 2009 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content.