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Critical Therapeutics' ZYFLO(R) Receives Distinct Classification under Medicare Prescription Drug Benefit.


LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that the Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS), previously known as the Health Care Financing Administration (HCFA), is a federal agency within the United States Department of Health and Human Services (DHHS) that administers the Medicare program and  (CMS (1) See content management system and color management system.

(2) (Conversational Monitor System) Software that provides interactive communications for IBM's VM operating system.
) has created a unique Formulary formulary /for·mu·lary/ (for´mu-lar?e) a collection of recipes, formulas, and prescriptions.

National Formulary  see under N.


for·mu·lar·y
n.
 Key Drug Type (FKDT FKDT Formulary Key Drug Type ) category for the Company's asthma drug, ZYFLO(R) (zileuton zileuton /zi·leu·ton/ (zi-loo´ton) an inhibitor of leukotriene formation, used as an antiasthmatic.
Zileuton (Zyflo) 
 tablets), under guidelines developed specifically for the Medicare Prescription Drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug,  Benefit (Part D).

This new category reflects the CMS' adoption of the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  Pharmacopeias' (USP USP - unique sales point ) 2007 Model Guidelines. Under the new FKDT, ZYFLO is now categorized as a "Synthesis Inhibitor" based on its pharmacologic distinction from other anti-leukotriene compounds, including Merck's Singulair(R), which are grouped together in a category known as "Receptor Antagonists." ZYFLO is the only 5-lipoxygenase (5-LO) inhibitor approved by U.S. Food and Drug Administration.

The USP Model Guidelines consist of a listing of therapeutic categories and associated pharmacologic classes that create a framework that prescription drug plans and others are encouraged to adopt as they create a drug plan formulary for patients enrolled under Medicare Part D plans. The FKDT designation for ZYFLO was one of only 23 newly added to the USP Model Guidelines for 2007.

"With ZYFLO as the only Synthesis Inhibitor under this FKDT, Critical Therapeutics has an opportunity to communicate the drug's unique positioning to Medicare plans and their patients," said Senior Vice President of Sales and Marketing, Frederick Finnegan. "Since most Medicare plans typically adopt these guidelines, the CMS classification should help to promote the availability of ZYFLO for patients whose symptoms have proven difficult to control with other asthma therapies."

About Zileuton and ZYFLO

Zileuton inhibits 5-lipoxygenase (5-LO), an enzyme that catalyzes the formation of leukotrienes Leukotrienes
A class of small molecules produced by cells in response to allergen exposure; they contribute to allergy and asthma symptoms.

Mentioned in: Leukotriene Inhibitors

leukotrienes
 from arachidonic acid arachidonic acid /arach·i·don·ic acid/ (ah-rak?i-don´ik) a polyunsaturated 20-carbon essential fatty acid occurring in animal fats and formed by biosynthesis from linoleic acid; it is a precursor to leukotrienes, prostaglandins, and . 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 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 bronchospasm /bron·cho·spasm/ (brong´ko-spazm) bronchial spasm; spasmodic contraction of the smooth muscle of the bronchi, as in asthma.

bron·cho·spasm
n.
 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;
. 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 Side effects

Effects of a proposed project on other parts of the firm.
 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 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 transaminase transaminase /trans·am·i·nase/ (-am´i-nas) aminotransferase.

trans·am·i·nase
n.
See aminotransferase.
 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 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 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, statements regarding the potential impact of the ZYFLO CMS classification on market acceptance of ZYFLO, and the possible therapeutic benefits of ZYFLO, may 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: the extent of market acceptance of ZYFLO; our ability to maintain regulatory approvals to market and sell ZYFLO; our ability to develop and maintain the necessary sales, marketing, distribution 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; the timing and success of submission, acceptance and approval of our regulatory filings, including, without limitation, the NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any  submission for the controlled-release formulation of zileuton; our heavy dependence on the commercial success of ZYFLO and the controlled-release formulation of zileuton; 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 Form 10-Q

See 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(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
Geographic Code:1USA
Date:May 25, 2006
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