Healthcare Industry News: zileuton
News Release - December 15, 2006
Critical Therapeutics Announces NIH-Sponsored Study to Investigate the Efficacy Of ZYFLO(R) In Patients with Acute Exacerbations Of COPDLEXINGTON, Mass.--(HSMN NewsFeed)--Critical Therapeutics, Inc. (Nasdaq: CRTX ) today announced that the National Institutes of Health (NIH) will sponsor and fund a clinical trial to evaluate whether using ZYFLO® (zileuton tablets) to treat patients admitted to the hospital with acute exacerbations of chronic obstructive pulmonary disease (COPD) will shorten their hospital stay. The clinical trial is scheduled to begin in the first quarter of 2007 and is being conducted by the COPD Clinical Research Network (CRN) in 10 U.S. centers. The trial is expected to enroll 520 patients.
COPD is the term used to describe two conditions - chronic bronchitis and emphysema - that damage the lungs and make breathing progressively more difficult. The disease, which is primarily caused by smoking(1), is the fourth leading cause of death in the U.S, claiming approximately 120,000 lives in 2002(2). In 2003, an estimated 10.7 million adults ages 25 and older had COPD(3). COPD accounted for more than 700,000 hospitalizations and 1.5 million emergency room visits in the United States in 2002(4).
The Phase III, double-blind, placebo-controlled clinical trial was designed by the Steering Committee of the COPD CRN. Patients who have been admitted to the hospital with acute exacerbations of COPD will be randomized to receive either oral placebo or zileuton (600 mg QID) for 14 days. The primary endpoint for this trial is the length of hospital stay for patients admitted with acute exacerbations of COPD. Additional clinical and biological endpoints will also be measured.
"With several clinical trials suggesting that leukotrienes are associated with lung inflammation during acute exacerbations of COPD, the NIH-sponsored COPD CRN is interested in investigating the potential of ZYFLO to speed recovery time and reduce hospital stay," said Critical Therapeutics Chief Medical Officer, Dana Hilt, M.D. "Currently, ZYFLO is the only approved drug that inhibits 5-lipoxygenase, an enzyme that catalyzes the formation of leukotrienes. As a result, we see an opportunity for zileuton to fill an unmet need for COPD patients and potentially expand the use of zileuton to other respiratory diseases beyond asthma."
About ZYFLO and zileuton
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, airway swelling, bronchoconstriction and mucus secretion.
ZYFLO, the immediate release tablet formulation of zileuton, blocks the formation of leukotrienes. ZYFLO is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. The recommended dose is one 600 mg tablet four times a day. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with ZYFLO can be continued during acute exacerbations of asthma. ZYFLO should be taken regularly, even during symptom-free periods.
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 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 developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to ZYFLO® (zileuton tablets), which is marketed in the United States for the prevention and chronic treatment of asthma in patients 12 years of age and older. Critical Therapeutics is working to expand its zileuton franchise by introducing a twice daily, controlled-release formulation for the prevention and chronic treatment of asthma and an intravenous formulation for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is collaborating with MedImmune, Inc. to design antibody therapies that treat acute and chronic diseases triggered by the inflammatory cytokine HMGB1. Research pipeline programs include lifecycle management to extend the zileuton franchise and an alpha-7 project for the treatment of inflammation. Critical Therapeutics is located in Lexington, Mass. For more information, please visit www.crtx.com.
Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding the funding or sponsorship of the ZYFLO COPD clinical trial by the NIH; the timing and outcome of the ZYFLO COPD clinical trial; possible therapeutic benefits and market acceptance of ZYFLO; the timing and success of regulatory filings, regulatory approvals and product launches; the efficacy of our drug candidates; prospects, plans and objectives of management; 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: difficulties or delays in the completion of patient enrollment, data collection or data analysis for the ZYFLO COPD clinical trial; a determination by the NIH to not sponsor or fund the ZYFLO COPD clinical trial or to postpone or delay the trial; whether the ZYFLO COPD clinical trial will demonstrate effectiveness of ZYFLO in treating COPD, including whether the results of prior clinical trials and preclinical studies will be indicative of results obtained in this clinical trial; the extent of market acceptance of ZYFLO and, if approved, the controlled-release formulation of zileuton (zileuton CR); our ability to maintain regulatory approvals to market and sell ZYFLO and, if approved, the zileuton CR; our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO and, if approved, zileuton CR; our ability to successfully market and sell ZYFLO with a reduced sales force; patient, physician and third-payer acceptance of ZYFLO and, if approved, zileuton CR, as a safe and effective therapeutic product; adverse side effects experienced by patients taking ZYFLO and, if approved, zileuton CR; the results of preclinical studies and clinical trials with respect to our products under development and whether such results will be indicative of results obtained in later clinical trials; the timing and success of submission, acceptance and approval of our regulatory filings, including the new drug application for zileuton CR; our heavy dependence on the commercial success of ZYFLO and, if approved zileuton CR; our ability to obtain the substantial additional funding required to conduct our research, development and commercialization activities; our dependence on our strategic collaboration with MedImmune, Inc.; 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 "Risk Factors" section of our most recent Quarterly Report on Form 10-Q and other filings that we make with the Securities and Exchange Commission (SEC). 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® is a registered trademark of Critical Therapeutics, Inc.
(1) U.S. Department of Health and Human Services. The Health Consequences of Smoking. A Report of the Surgeon General, 2004.
(2) National Center for Health Statistics. Report of Final Mortality Statistics, 2002.
(3) American Lung Association, Chronic Obstructive Pulmonary Disease Fact Sheet, July 2005.
(4) Centers for Disease Control and Prevention, Facts About Chronic Obstructive Pulmonary Disease, August 2003.
Source: Critical Therapeutics
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.