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Critical Therapeutics Presents Safety Data for Twice Daily, Controlled-Release Formulation of Zileuton at CHEST 2006.


Poster Presentation Highlights That Safety Profile of Zileuton zileuton /zi·leu·ton/ (zi-loo´ton) an inhibitor of leukotriene formation, used as an antiasthmatic.
Zileuton (Zyflo) 
 CR is Similar to Placebo

LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced the presentation of a poster highlighting data from a placebo-controlled study demonstrating that the controlled-release (CR) tablet formulation of zileuton (1200 mg BID), an investigational drug, was generally well tolerated and the adverse event profile was similar to placebo and similar to that seen with ZYFLO[R] (zileuton tablets), the immediate release (IR) formulation of zileuton currently marketed by the Company. In addition the poster provides highlights of the efficacy results showing that zileuton CR provides early and sustained improvement in lung function compared with placebo. Zileuton CR is a 5-lipoxygenase (5-LO) inhibitor designed to block the production of the 5-LO, an enzyme responsible for asthma symptoms. The poster, "Safety of Zileuton Controlled-Release Tablets Given Twice Daily for the Treatment of Asthma: A Placebo-Controlled Study," by Dr. Leonard Bielory et al., is on display at the American College of Chest Physicians The American College of Chest Physicians (ACCP) is a medical organization consisting of physicians and non-physician specialists in the field of chest medicine, which includes pulmonology, thoracic surgery, and critical care medicine.  (CHEST) 2006 meeting in Salt Lake City.

Data presented in the poster is based on a 16-week randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, double-blind, multi-center, placebo-controlled study. A total of 613 patients were randomized into the double-blind dosing period. The objective was to compare the efficacy and safety of zileuton CR 1200 mg (n=206) with placebo (n=203). A ZYFLO arm (n=101) and ZYFLO placebo arm (n=101) were included as a benchmark comparison with previous ZYFLO efficacy studies.

Patients enrolled in the zileuton CR arms had a mean baseline percent of predicted normal forced expiratory volume forced expiratory volume
n. Abbr. FEV
The maximum volume of air that can be expired from the lungs in a specific time interval when starting from maximum inspiration.
 (FEV FEV forced expiratory volume.

FEV
abbr.
forced expiratory volume



FEV

forced expiratory volume.
1) of 58.5%. There was a similar incidence of adverse events in the zileuton CR and placebo groups. The most commonly reported adverse events (greater than or equal to 5) were exacerbation of asthma, headache, sinusitis sinusitis

Inflammation of the sinuses. Acute sinusitis, usually due to infections such as the common cold, causes localized pain and tenderness, nasal obstruction and discharge, and malaise.
, nausea, nasopharyngitis and pharyngolaryngeal pain. The incidence of elevations in alanine aminotransferase alanine aminotransferase /al·a·nine ami·no·trans·fer·ase/ (ah-me?no-trans´fer-as) alanine transaminase.

alanine aminotransferase
n. Abbr. ALT
See SGPT.
 was similar to data reported previously in clinical studies of ZYFLO[R] (zileuton IR 600 mg QID QID Quater In Die (Latin: Four Times A Day)
QID Quad Information Display (Matrox)
QID Quality Insights of Delaware
QID Question Identification Number (finance) 
).

The New Drug Application for zileuton CR was submitted to the U.S. Food and Drug Administration on July 31, 2006. The Prescription Drug User Fee Act The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.  (PDUFA PDUFA Prescription Drug User Fee Act of 1992 (USA) ) date is May 31, 2007. Pending regulatory approval, the Company expects to launch the product in the second half of 2007.

About CHEST 2006

CHEST 2006, the multidisciplinary world congress on diseases of the chest, brings together pulmonary, sleep and critical care experts to present the latest research related to clinical chest medicine. The conference hosts 500 national and international experts and up-and-coming investigators as they present their cutting-edge research abstracts and case reports. Abstracts of the posters are available by clicking on the "CHEST 2006" link at http://www.chestnet.org/CHEST/acr/index.php.

About ZYFLO[R]

ZYFLO[R] is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO is not indicated for use in the reversal of broncospasm in acute asthma attacks, including status asthmaticus status asth·mat·i·cus
n.
A condition of severe, prolonged asthma.


status asthmaticus Pulmonology A condition characterized by ↓ response in asthmatics to drugs for which they had previously been sensitive;
. Patients with active liver disease Liver Disease Definition

Liver disease is a general term for any damage that reduces the functioning of the liver.
Description

The liver is a large, solid organ located in the upper right-hand side of the abdomen.
 or liver enzymes that are elevated should not take ZYFLO. For full prescribing information for ZYFLO, 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. ZYFLO is the only 5-lipoxygenase inhibitor approved for marketing by the U.S. Food and Drug Administration. 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, all statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
: the extent of market acceptance of the Company's products; the Company's heavy dependence on the commercial success of ZYFLO and the controlled-release formulation of zileuton; our ability to maintain regulatory approvals to market and sell ZYFLO; whether the results referred to in this release will be interpreted by the U.S. Food and Drug Administration or patients, physicians and third-party payers in the same manner as the Company; adverse side effects Side effects

Effects of a proposed project on other parts of the firm.
 experienced by patients taking ZYFLO and the impact of the Company's other zileuton product candidates, 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 Form 10-Q

See 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Article Type:Clinical report
Date:Oct 25, 2006
Words:1005
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