Critical Therapeutics completes intravenous zileuton trial in asthma patients

By Elaine Rigoli

Tampa, Fla., July 25 - Critical Therapeutics, Inc. said it completed the double-blind, placebo-controlled, single-dose phase 1/ 2 clinical trial of the intravenous formulation of zileuton for use in patients who suffer acute exacerbations of asthma.

Dosing began in February and preliminary results are expected later this quarter, the company said in a news release.

The trial is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients. Patients dosed in the study had a baseline lung function of 40% to 80% of predicted normal, as measured by forced expiratory volume.

This trial is the first time an intravenous formulation of a 5-lipoxygenase inhibitor has been tested in humans, the release said.

Critical Therapeutics is a biopharmaceutical company based in Lexington, Mass.

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