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Critical Therapeutics Initiates Open-Label Study of ZYFLO; Study Provides Certain Patients Access to ZYFLO Prior to Commercial Availability

Posted on: Monday, 14 March 2005, 09:00 CST

Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that it has initiated an open-label, Phase IIIb study of its investigational drug, ZYFLO(R) Filmtab(R) (zileuton tablets), for patients with asthma who have previously benefited from ZYFLO and require it to control their asthma. In addition, the U.S. Food and Drug Administration (FDA) has approved the enrollment in the study of patients with mastocytosis, an orphan disease involving new or abnormal cell growth, where ZYFLO is deemed essential for the treatment of symptoms.

ZYFLO is the only 5-lipoxygenase inhibitor approved in the United States for the treatment of asthma in adults and children 12 years of age and older. Critical Therapeutics licensed exclusive worldwide rights to ZYFLO and other forms of zileuton from Abbott Laboratories and is in the process of transferring the manufacturing to new sites. The Company expects to submit a supplemental new drug application (sNDA) to the FDA for the change in manufacturing process and sites and, subject to FDA approval of these new manufacturing sites, expects ZYFLO to be commercially available in the fourth quarter of 2005. ZYFLO has been commercially unavailable since early 2004, when Abbott Laboratories' remaining supply was depleted.

"We are pleased to be allowed to begin this open-label study, as it enables us to fulfill many requests from physicians and previous asthma patients who responded to ZYFLO and require continued therapy to control their asthma," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "For patients who have previously benefited from ZYFLO, this study serves as an important bridge until approval and commercial availability."

Trial enrollment will proceed until Critical Therapeutics receives authorization from the FDA to market ZYFLO in the United States, or until 18 months have lapsed, whichever occurs first. Details regarding the open-label study are available on Critical Therapeutics' website at www.crtx.com.

ZYFLO is not indicated for the reversal of bronchospasm in acute asthma attacks or for the prevention or treatment of mastocytosis.

Background on Mastocytosis

Mastocytosis is an orphan disease that involves new or abnormal cell growth, specifically mast cell proliferation. Symptoms vary from person to person and may occur as "attacks" or simply as fatigue and a feeling of ill health. Symptoms experienced by people with mastocytosis include nausea, vomiting, abdominal cramping, diarrhea, excess stomach acid or ulcers, unexplained fractures, mild-to-severe pain in bones, joints, or muscles, enlargement of liver or spleen, bladder pain, heart palpitations or rapid heart beat, chest discomfort, shortness of breath, light-headedness, fatigue, weakness, weight loss, and respiratory symptoms, including asthma.

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 is developing a sales and marketing infrastructure in connection with its in-licensed product, ZYFLO(R) Filmtab(R), a tablet formulation of zileuton. 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

Statements in this press release that are not strictly historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, which include statements with respect to the timing of submission of an sNDA to the FDA and the timing of commercial launch of ZYFLO, are subject to numerous risks and uncertainties that may cause actual events or results to differ materially from those set forth in the statements. No forward-looking statements can be guaranteed, and actual results may differ materially from those projected as a result of various important factors, including risks relating to: the results of clinical trials with respect to our products under development; the timing and success of submission, acceptance and approval of our regulatory filings; our heavy dependence on the commercial success of ZYFLO tablets 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 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 periodically file 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. All forward-looking statements reflect our beliefs and expectations as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments will cause our views 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.

ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc. Filmtab(R) is a registered trademark of the Abbott Group of Companies.

Source: Business Wire

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