LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that the 30-day waiting period relating to the Company's Investigational New Drug application for the intravenous formulation of zileuton (zileuton IV) has ended. The Company plans to begin a Phase I/II study of zileuton IV in the United States in the first quarter of 2006. Critical Therapeutics owns worldwide rights to the zileuton franchise, including ZYFLO(R), an FDA-approved oral tablet formulation that the Company is marketing in the United States for the prevention and chronic treatment of asthma in adults and children 12 years of age and older.
The Phase I/II study will assess the safety, tolerability, pharmacokinetics and exploratory efficacy of zileuton IV in patients with asthma. The double-blind, placebo-controlled, single-dose, multicenter study will be conducted in 60 patients with asthma and baseline FEV1 (forced expiratory volume), a lung-function measure, of 40%-80% of predicted normal. The study will mark the first time that zileuton IV has been tested in humans. As an oral product zileuton has been evaluated in clinical studies involving more than 5,000 asthma patients.
"Our clinical development program for zileuton IV is part of our plan to bring the complementary components of our zileuton franchise to the market in a focused and efficient manner," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "Acute asthma is a common cause of emergency room (ER) visits and is responsible for approximately two million ER visits and nearly 500,000 hospital admissions in the United States annually. We believe that zileuton IV has the potential to benefit asthmatics who suffer from acute exacerbations. Clinical data demonstrates that oral zileuton's maximum effect on lung function correlates with blood drug concentration reaching peak level. As a result, we believe that the intravenous formulation may provide rapid onset of action because it could reach peak blood concentration rapidly following the time of injection."
About Zileuton and ZYFLO
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, the 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. Therapy with ZYFLO can be continued during acute exacerbations of asthma. ZYFLO should be taken regularly, even during symptom-free periods.
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 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 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.
Critical Therapeutics 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 study of zileuton 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(R) is a registered trademark of Critical Therapeutics, Inc.
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