Critical Therapeutics' Sales Force Gains Access to a Second Product as FDA Approves Co-Promotion Partner's New Treatment for COPD.

FDA Approves DEY's New Drug Application for Perforomist(TM) Inhalation Solution

LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved Dey, L.P.'s (DEY) New Drug Application for Perforomist(TM) (formoterol fumarate) Inhalation Solution for long-term, twice-daily maintenance treatment of bronchoconstriction for emphysema and chronic bronchitis, also known as Chronic Obstructive Pulmonary Disease (COPD). Perforomist(TM) Inhalation Solution was approved as a 505(b)2 New Drug Application (NDA) that cross references Foradil[R] in support of safety and efficacy. Under the terms of their binding letter agreement, Critical Therapeutics and DEY, an affiliate of Merck KGaA in Germany, will jointly promote Perforomist(TM) Inhalation Solution in the United States. In order to participate in the promotion of Perforomist(TM) Inhalation Solution, Critical Therapeutics must increase its sales force to at least 40 representatives, which it intends to do upon regulatory approval of its twice-daily, controlled-release formulation of zileuton (zileuton CR).

Formoterol is a rapid and long-lasting beta(2)-agonist that has been previously approved in the U.S. as a dry powder formulation, and the molecule has 20 years of world-wide use. Perforomist(TM) Inhalation Solution is the first and only FDA-approved nebulized formoterol fumarate. Nebulizers convert liquid medication into a mist that patients inhale through a mouthpiece or face mask.

"The approval of Perforomist(TM) Inhalation Solution enhances the prospective efficiency of our sales force by providing representatives with a second product that directly complements our respiratory franchise," said Frank Thomas, President and Chief Executive Officer of Critical Therapeutics. "We are very pleased about the opportunity to co-promote Perforomist(TM) Inhalation Solution and the opportunity to provide a new long-term treatment option for COPD patients."

On March 13, 2007, Critical Therapeutics and DEY entered into an agreement for the joint promotion of ZYFLO[R] (zileuton Tablets) and zileuton CR, which is currently under review at the FDA. Zileuton CR has a Prescription Drug User Fee Act (PDUFA) date of May 31, 2007. ZYFLO is the FDA-approved immediate-release formulation of zileuton, a four-times daily medication for asthma in patients 12 years of age and older. Zileuton CR is a twice-daily, controlled-release formulation that, upon FDA approval, will be marketed for asthma patients 12 years of age and older. Zileuton CR utilizes SkyePharma PLC's Geomatrix[R] technology.

About Perforomist [TM] (Formoterol Fumarate) Inhalation Solution

The clinical evaluations of Perforomist[TM] Inhalation Solution included two clinical trials involving a total of 1,045 patients. In the product's pivotal Phase III trial, 351 patients participated in a 12-week, multi-center, safety and efficacy COPD study. In the study, 123 COPD patients were treated with Perforomist[TM] Inhalation Solution 20 mcg/2 mL twice daily, 114 COPD patients were treated with the active comparator (Foradil[R]), and 114 COPD patients were treated with placebo. The study's results showed that Perforomist[TM] Inhalation Solution 20 mcg/2 mL taken twice daily was statistically superior to placebo for the primary endpoint, FEV(1) AUC(0-12). The safety and efficacy of Perforomist[TM] Inhalation Solution observed in this study were comparable to those of Foradil[R]. Additionally, patients treated with Perforomist[TM] Inhalation Solution used less rescue albuterol during the trial compared to patients treated with placebo.

About COPD

COPD refers to a number of chronic lung disorders in which the airways to the lungs become narrowed and breathing becomes increasingly difficult. The most common forms of COPD are chronic bronchitis and emphysema, and many patients suffer from a combination of the two diseases.

COPD is the fourth leading cause of death in America, behind heart disease, cancer and stroke. Twelve million Americans have been diagnosed with COPD and at least another 12 million have symptoms but are not diagnosed. COPD is not well understood or recognized - most Americans have not heard of it, not even those who may be living with the condition. The most common cause of COPD is cigarette smoking, which is responsible for an estimated 80 to 90 percent of COPD cases. Estimates of the total incidence of COPD in America range from 24 to 30 million.

About Nebulization 

Perforomist[TM] Inhalation Solution is a long-acting bronchodilator that is taken by nebulizer. Of the three types of devices used to deliver bronchodilators -- nebulizers, metered-dose inhalers, and dry powder inhalers -- nebulizers may offer the easiest method because they require no special technique or coordination, as the medication is converted into a fine mist that the patient inhales through a mouthpiece or face-mask while breathing naturally. Because nebulization is an easy, effective, and thorough method of delivering medicine directly into the lungs, many COPD patients prefer it, particularly as they become increasingly frail due to their disease progression.

Perforomist[TM] Inhalation Solution changes the paradigm regarding nebulization. Now, nebulization may become a more valuable and widely used treatment option for the millions of COPD patients at earlier treatment stages who would benefit from twice-daily maintenance dosing of a nebulized LABA such as Perforomist[TM] Inhalation Solution. For example, the clinical benefit of this new COPD treatment may be a valuable clinical option for patients who are not adequately controlled with short-acting bronchodilators.

Indication

Perforomist[TM] Inhalation Solution is indicated for the long-term, twice- daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema.

Important Safety Information

Perforomist[TM] Inhalation Solution belongs to a class of medications known as long-acting beta(2)-adrenergic agonists (LABAs). LABAs may increase the risk of asthma-related death. Data from a large placebo-controlled US study comparing the safety of another LABA (salmeterol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol may apply to formoterol (a LABA), the active ingredient in Perforomist[TM] Inhalation Solution.

Perforomist[TM] Inhalation Solution should not be used in patients with acutely deteriorating COPD or to treat acute symptoms. Acute symptoms should be treated with fast-acting rescue inhalers. Perforomist[TM] Inhalation Solution should not be used with other medications containing LABAs. Do not use more than one nebule twice daily. Perforomist[TM] Inhalation Solution should be used with caution in patients with cardiovascular disorders. Perforomist[TM] Inhalation Solution is not a substitute for inhaled or oral corticosteroids. The safety and efficacy of Perforomist[TM] Inhalation Solution in asthma has not been established. In COPD clinical trials, the most common adverse events reported with Perforomist[TM] Inhalation Solution were diarrhea, nausea, nasopharyngitis, dry mouth, vomiting, dizziness, and insomnia.

About ZYFLO and Zileuton

ZYFLO([R]) (zileuton Tablets) is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. 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 is the only 5-LO inhibitor approved for marketing by the U.S. Food and Drug Administration. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. 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, headquartered Lexington, MA, is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to ZYFLO[R] (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 developing a twice daily, controlled-release formulation for the prevention and chronic treatment of asthma and an injectable 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. 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 possible therapeutic benefits, market acceptance and future sales of ZYFLO and, if approved, zileuton CR; the anticipated success of our co-promotion arrangements with DEY, including with respect to Perforomist(TM) Inhalation Solution; the progress, timing and success of our regulatory filings, regulatory approvals and product launches, including for zileuton CR; the anticipated increase in our number of sales representatives and whether the co-promotion for Perforomist(TM) Inhalation Solution will become effective, 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 expected timing and outcome of the new drug application (NDA) for zileuton CR and related discussions with the FDA, including our ability to rely on historical data in the NDA and the sufficiency and acceptability of the results of pharmacokinetic studies of zileuton CR for FDA purposes; our ability to successfully market and sell ZYFLO and, if approved, zileuton CR, including the success of our co-promotion arrangement with DEY; our ability to successfully promote Perforomist(TM) Inhalation Solution pursuant to our co-promotion arrangement with DEY; our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO, and, if approved, zileuton CR; patient, physician and third-party payor 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; our heavy dependence on the commercial success of ZYFLO and, if approved, zileuton CR; our ability to maintain regulatory approvals to market and sell ZYFLO and, if approved, zileuton CR; our ability to successfully enter into additional strategic co-promotion, collaboration or licensing transactions on favorable terms, if at all; conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; 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, zileuton CR, our discoveries and our drug candidates. 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. 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.

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. Perforomist(TM) is a trademark of Dey, L.P. Foradil[R] (formoterol fumarate) is a registered trademark of Novartis Pharmaceuticals.