Critical Therapeutics, Inc. Announces Results Of Phase I/II Trial Of Intravenous Formulation Of Zileuton

LEXINGTON, Mass.--(BUSINESS WIRE)--Aug. 23, 2006-- Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced the results of its Phase I/II clinical trial designed to evaluate safety, tolerability and pharmacokinetics of the intravenous formulation of zileuton (zileuton IV) in patients with asthma. In addition, the trial included measurements to detect evidence of improvement in lung function. The double-blind, placebo-controlled trial enrolled 60 patients at 10 clinical sites in the United States. Patients enrolled in the trial had a mean FEV(1) (forced expiratory volume in one second) of 63 percent of predicted normal at baseline and a mean age of 40 years. Patients enrolled in the trial were randomized into four escalating dose groups (75 mg, 150 mg, 300 mg, and 600 mg), each receiving one infusion of either zileuton IV or placebo. Each of the four dose groups enrolled 15 patients, of whom 12 received zileuton IV and three received placebo. All 60 patients who were randomized completed the trial.