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Critical Therapeutics' ZYFLO(R) Reduces Need for Rescue Medication and Significantly Improves Lung Function in Severe Asthma Patients

Posted on: Wednesday, 2 November 2005, 18:00 CST

Critical Therapeutics Announces Presentation of Scientific Posters at CHEST 2005 Meeting in Montreal

Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced the presentation of two scientific posters demonstrating that ZYFLO(R) (zileuton tablets) significantly improved the lung function of patients with severe asthma, while reducing their need for rescue medications and oral corticosteroids.

Lead authors of the information presented at the American College of Chest Physicians (ACCP) CHEST 2005 meeting in Montreal, Canada were Dr. William E. Berger, professor of allergy and immunology at the University of California, Irvine, and Dr. Mark C. Liu, associate professor at the Johns Hopkins University School of Medicine in Baltimore. Data presented in both posters were derived from retrospective analyses of a six month randomized, placebo-controlled, double-blind, parallel, multi-center safety and efficacy study of zileuton.

Improved Pulmonary Function

Dr. Berger's poster contained data from 231 asthma patients stratified into moderate (n=133) and severe (n=98) asthma subgroups based on baseline percent predicted normal forced expiratory volume (FEV1), a measure of lung function. Pulmonary function measurements were obtained from patients on 600 mg zileuton four times per day (the prescribed dose) compared with placebo 30, 60 and 120 minutes post-dose.

Data in the poster noted that both moderate and severe asthmatic patients in the zileuton group experienced "rapid and sustained improvement in pulmonary function," compared with placebo, as early as 30 minutes after receiving zileuton.

Clinically Relevant Reductions in the Need for Rescue Medications

Dr. Malcolm Blumenthal of the University of Minnesota, a co-author with Dr. Liu, presented data demonstrating that, for severe asthma patients (n=98), the prescribed dose of zileuton provided improvement versus placebo in markers of asthma control. These included reductions in daily and night-time symptoms, the daily number of occasions of beta-agonist use and asthma exacerbations requiring alternative treatment and oral corticosteroids. For example, only 5.9% of the severe asthma patients in the zileuton group required oral corticosteroids, compared with 25.5% of severe asthma patients on placebo (p less than or equal to 0.010).

"As we begin to introduce ZYFLO to thousands of respiratory specialists across the country, the data presented reinforces the concept that ZYFLO may provide effective treatment for severe asthma patients whose symptoms are not effectively managed by beta-agonists and oral corticosteroids," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics.

5-LO Symposium

In addition to the poster presentation, Critical Therapeutics supported an educational symposium at the ACCP titled "5-Lipoxygenase: Exploring the Pathway." The symposium featured a panel of experts on allergy, asthma and upper airway disease.

About CHEST 2005

ACCP CHEST 2005, 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 2005" link at http://www.chestnet.org/CHEST/acr/index.php.

About ZYFLO

ZYFLO 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. Patients with active liver disease 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. 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 maintain regulatory approvals to market and sell ZYFLO; 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.

Source: Business Wire

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