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Critical Therapeutics Announces Research on ZYFLO(R) Presented at 2006 AAAAI Annual Meeting

07 Mar 2006

Announced that two scientific posters on ZYFLO(R) (zileuton tablets) were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2006 Annual Meeting

LEXINGTON, MA, USA | Mar 06, 2006 | Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that two scientific posters on

ZYFLO(R) (zileuton tablets) were presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2006 Annual Meeting in Miami Beach, Florida.

William E. Berger, M.D., of Southern California Research, Mission Viejo, California, and Robert A. Nathan, M.D., of Asthma and Allergy Associates in Colorado Springs, Colorado, were lead authors of the posters.

The data were generated from retrospective analyses of two pivotal, randomized, placebo-controlled, double-blind, parallel, multi-center studies of the safety and efficacy of zileuton in 966 asthmatics. Both posters contained data from 483 asthma patients stratified into two patient groups, those with baseline forced expiratory volume (FEV(1)), a measure of lung function, of greater than 60%- less than 80% (n=257) and those with FEV(1) of less than or equal to 60% (n=226). Lung function measurements were obtained from patients on 600 mg zileuton four times per day (the prescribed dose) compared with placebo.

Lung Function

Data in Dr. Berger's poster noted that both zileuton patient groups experienced improvement in trough FEV(1) and peak expiratory flow rate (PEFR) compared with placebo.

Rescue Medication Use

Data in Dr. Nathan's poster noted that both zileuton patient groups showed decreases in asthma symptoms compared with placebo. Both zileuton patient groups also demonstrated a reduced need for beta-agonists and corticosteroid rescue.

The AAAAI is the largest professional medical specialty organization in the United States representing allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic disease. The 2006 AAAAI Annual Meeting is being held March 3-7 in Miami Beach, Florida. Abstracts of the posters presented by Dr. Berger and Dr. Nathan are available by clicking on the "Annual Meeting Abstracts" link at http://www.aaaai.org/members/annual_meeting/am2006//.

About ZYFLO/Zileuton

ZYFLO(R) (zileuton tablets) is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton inhibits 5-lipoxygenase (5-LO), an enzyme that catalyzes the formation of leukotrienes from arachidonic acid. 5-LO is the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. ZYFLO is the only 5-LO inhibitor approved for marketing by the U.S. Food and Drug Administration.

ZYFLO is not indicated for use in the reversal of broncospasm in acute asthma attacks, including status asthmaticus. Mild to moderate side effects associated with the use of ZYFLO are abdominal pain, upset stomach and nausea. A small percentage of patients treated with ZYFLO show an increased release of a liver enzyme known as ALT. As a result, the level of liver enzymes in patients treated with ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO and repeat the test on a regular basis while patients are on the medication. ZYFLO is contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal.

For full prescribing information, please visit www.crtx.com/pat_pi.html or call the Company's toll free telephone number 1-866-835-8216 to request medical information.

About Critical Therapeutics

Critical Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to the asthma drug ZYFLO(R) (zileuton tablets), as well as other formulations of zileuton. The Company's commercialization efforts for ZYFLO are carried out by its 80-person specialty sales force. Critical Therapeutics also is developing treatments directed toward the severe inflammatory response in acute diseases and conditions that lead to admission to the emergency room or intensive care unit, and acute exacerbations of other chronic diseases that frequently lead to hospitalization. For more information, please visit www.crtx.com.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, possible therapeutic benefits and market acceptance of ZYFLO and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "will," "would" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties relating to: the extent of market acceptance of ZYFLO; our heavy dependence on the commercial success of ZYFLO and the controlled-release formulation of zileuton; our ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to commercialize ZYFLO; patient, physician and third-payer acceptance of ZYFLO as a safe and effective therapeutic product; adverse side effects experienced by patients taking ZYFLO, our ability to obtain the substantial additional funding required to conduct our research, development and commercialization activities; and our ability to obtain, maintain and enforce patent and other intellectual property protection for ZYFLO, our drug candidates and our discoveries. These and other risks are described in greater detail in the "Factors That May Affect Future Results" section of our most recent Quarterly Report on Form 10-Q and other filings that we make with the Securities and Exchange Commission. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

In addition, the statements in this release reflect our expectations and beliefs as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.

ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc.

CONTACT: Critical Therapeutics, Inc.
Linda S. Lennox, 781-402-5708
Senior Director, Investor and Media Relations
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SOURCE: Critical Therapeutics, Inc

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