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Critical Therapeutics Announces the Publication of Data for ZyfloCR,(Zileuton) Extended-Release Tablets in the Journal of Asthma

LEXINGTON, Mass.--(BUSINESS WIRE)--Jun 12, 2007 - Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced the publication of data from a pivotal Phase III clinical trial of ZYFLO CR(TM) (zileuton) extended-release tablets in the June 2007 issue of the Journal of Asthma. ZYFLO CR was approved by the U.S. Food and Drug Administration (FDA) on May 30, 2007. Critical Therapeutics, together with its co-promotion partner Dey, L.P. (DEY), expects to begin marketing ZYFLO CR in the U.S. in the fall of 2007. ZYFLO CR and the immediate release formulation of zileuton, ZYFLO(R) (zileuton tablets), are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR and ZYFLO are not indicated for use in the reversal of bronchospasm in acute asthma attacks, but can be continued during acute exacerbations of asthma.

The study, titled "The Safety and Efficacy of Zileuton Controlled-Release Tablets as Adjunctive Therapy to Usual Care in the Treatment of Moderate Persistent Asthma: A 6-Month Randomized Controlled Study," was conducted primarily to assess the long-term safety of adding ZYFLO CR to a patient's usual asthma treatment regimen. The secondary objective was to evaluate the efficacy as well as to determine the effect on certain health outcomes of ZYFLO CR plus usual care, compared with placebo plus usual care. The results of the study show that the incidence of liver function elevations with ZYFLO CR were similar to data reported previously in clinical studies of ZYFLO (600 mg QID). Authors of the paper also observed sustained improvements in AM and PM peak expiratory flow in the ZYFLO CR group compared to placebo.

Study Design and Results

The multi-center, double-blind, placebo-controlled study was designed to primarily assess the safety of ZYFLO CR 1,200 mg BID added to usual care (n=619), compared w
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