Healthcare Industry News:  zileuton 


 News Release - February 15, 2006

Critical Therapeutics Completes Dosing of First Patient in Clinical Trial of Intravenous Zileuton

LEXINGTON, Mass.--(HSMN NewsFeed)--Feb. 15, 2006--Critical Therapeutics, Inc. (Nasdaq: CRTX ) today announced that it has enrolled and dosed the first patient in its Phase I/II clinical trial of intravenous (IV) zileuton in patients with asthma. The double-blind, placebo-controlled, single-dose trial is being conducted at multiple centers in the United States.

The Phase I/II clinical trial is designed to evaluate the IV formulation's safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients, pre-screened for response to oral zileuton, whose baseline lung function is 40%-80% of predicted normal, as measured by FEV1 (forced expiratory volume). It is the first time an IV formulation of a 5-lipoxygenase inhibitor has been tested in humans. By initiating the clinical trial in patients, the Company should be able to gain insights into the drug's effect on lung function. As an oral drug, zileuton has been studied in clinical trials involving more than 5,000 asthma patients. In October 2005, Critical Therapeutics began marketing ZYFLO®, a four-times-per-day tablet formulation of zileuton, in the United States for the prevention and chronic treatment of asthma in patients 12 years of age and older.

This study is designed to enroll patients into four escalating dose groups, with each patient receiving one infusion of either IV zileuton or placebo. Lung function measurements will be taken prior to dosing and at additional times during the 24-hour period after the infusion. All patients will be followed for up to three days post-infusion, primarily to assess the safety of zileuton IV.

"This trial is our first clinical step toward developing IV zileuton as an additional therapy for emergency room management of acute asthma - an area that has not had any new treatment options in a number of years," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "According to the American Lung Association, acute asthma attacks result in nearly two million emergency room visits in the United States each year, and about 25 percent of those patients end up hospitalized. Oral zileuton's rapid onset of action is well established. Based on the drug's pharmacological profile, the IV formulation has the ability to achieve peak blood concentration within minutes, providing the potential to become part of a new treatment regimen in the acute care setting."

About 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, swelling, bronchoconstriction and mucus secretion.

ZYFLO Safety Information

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 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® (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

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding the progress and timing of the zileuton IV program, the expected results of our Phase I/II clinical study of zileuton IV 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 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; conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the timing and success of submission, acceptance and approval of our regulatory filings; our heavy dependence on the commercial success of ZYFLO and the approval of the controlled-release formulation of zileuton currently in development; 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 "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® is a registered trademark of Critical Therapeutics, Inc.

Source: Critical Therapeutics

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