Critical Therapeutics Announces Publication of Results from Two Asthma Studies.

LEXINGTON, Mass. -- Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that in a clinical trial published in the August 2007 issue of the peer-reviewed journal Annals of Allergy, Asthma & Immunology (AAAI), ZYFLO CR(TM) (zileuton) extended-release tablets demonstrated significantly improved lung function in moderate persistent asthma patients compared to placebo. Separately, the results from a clinical trial of the immediate -release formulation of zileuton, ZYFLO[R] (zileuton tablets), demonstrating safety in patients with chronic asthma were published in the Drug Safety edition of the Official Journal of the International Society of Pharmacovigilance.

"Publication of the results of the efficacy trial in AAAI underscores the value of ZYFLO CR as a unique treatment with the ability to improve lung function in asthma patients," said Frank Thomas, president and chief executive officer of Critical Therapeutics. "As a twice-daily tablet, ZYFLO CR simplifies the dosing regimen compared with ZYFLO, which is taken four-times daily, while maintaining a similar safety and efficacy profile to ZYFLO."

Data published in AAAI was from a Phase III multicenter, randomized study that was designed to evaluate the efficacy of ZYFLO CR compared with placebo. In this trial, patients were randomized into four treatment groups: ZYFLO CR (1200 mg), twice daily (n=206); placebo CR, twice daily (n=203); zileuton immediate-release tablets (ZYFLO), 600 mg four times daily (n=101); or placebo IR, four times daily (n=103), for 12 weeks. The primary efficacy endpoint was a change from baseline in forced expiratory volume in one second (FEV1), a measurement of lung function. ZYFLO and placebo IR were included to establish a benchmark comparison.

At week 12, patients receiving ZYFLO CR showed a statistically significant mean improvement of 0.39-L in FEV1 (20.8%), compared with a mean improvement of 0.27-L (12.7%) in the placebo CR group. The proportion of patients who showed 12% or greater improvement in FEV1 over baseline was significantly higher in the ZYFLO CR group than the placebo CR group at all time points.

Data published in Drug Safety was from a 12-month open-label, safety surveillance study that was designed primarily to evaluate the long-term safety of ZYFLO and to establish appropriate LFT monitoring guidelines. This long-term clinical trial was conducted in patients using ZYFLO as an adjunctive treatment to usual asthma care. In this trial, patients were randomized into two groups, ZYFLO (600 mg), four times daily plus usual care (n=2,458); or usual care treatment only (n=489). Safety assessments were performed at each scheduled office visit during the 12-month period.

The results of the trial indicate that the nature of zileuton-associated liver injury is hepatocellular in nature and generally occurs within three months of starting therapy and typically resolves within one month of discontinuing therapy. The trial demonstrated that liver enzyme monitoring was effective in detecting elevation of ALT levels and, with appropriate liver enzyme monitoring, the risk of irreversible liver injury appeared to be low. The majority (64.2%) of patients who had elevated ALT levels in this trial experienced the occurrence during the first three months of treatment. After three months, the risk of elevated ALT levels in zileuton-treated patients in the study fell toward that observed in patients receiving usual care.

About ZYFLO CR and ZYFLO

ZYFLO CR and ZYFLO are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR and ZYFLO are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR and ZYFLO can be continued during acute exacerbations of asthma. ZYFLO CR uses SkyePharma PLC's (LSE: SKP) proprietary Geomatrix[R] drug delivery technology, which controls the amount and rate of drug released into the body.

The recommended dose of ZYFLO CR is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. The recommended dose of ZYFLO is one 600 mg immediate-release tablet four times a day for a total daily dose of 2400 mg.

ZYFLO CR and ZYFLO are contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal. A small percentage of patients treated with ZYFLO CR (2.5%) and ZYFLO (1.9%) in placebo-controlled trials showed an increased release of a liver enzyme known as ALT and bilirubin (an orange or yellowish pigment in bile). As a result, the level of liver enzymes in patients treated with ZYFLO CR and ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR and ZYFLO and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR or ZYFLO and theophylline should reduce the theophylline dose by 50%. Patients taking ZYFLO CR or ZYFLO and propranolol or warfarin should be monitored and doses adjusted as appropriate. Most common side effects associated with the use of ZYFLO CR and ZYFLO are sinusitis, nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea, respectively.

For full prescribing information for ZYFLO CR, please visit www.zyflocr.com or call the Company's toll free telephone number 1-866-835-8216 to request medical information.

For full prescribing information for ZYFLO, please visit www.zyflo.com or call the Company's toll free telephone number 1-866-835-8216 to request medical information.

About Critical Therapeutics

Critical Therapeutics, Inc. is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to two FDA-approved drugs for the prevention and chronic treatment of asthma in patients 12 years of age and older: twice-daily ZYFLO CR(TM) (zileuton extended-release tablets) and ZYFLO([R]) (zileuton immediate-release tablets). Critical Therapeutics is working to develop products for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is developing therapies directed toward the body's inflammatory response. Critical Therapeutics is located in Lexington, Mass. 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 possible therapeutic benefits of ZYFLO CR and ZYFLO 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: our ability to successfully market and sell ZYFLO CR and ZYFLO, including the success of our co-promotion arrangement with Dey, L.P. (DEY); our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO CR and ZYFLO; patient, physician and third-party payor acceptance of ZYFLO CR and ZYFLO as a safe and effective therapeutic product; adverse side effects experienced by patients taking ZYFLO CR and ZYFLO; our heavy dependence on the commercial success of ZYFLO CR and ZYFLO; our ability to maintain regulatory approvals to market and sell ZYFLO CR and ZYFLO; 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 CR and ZYFLO, 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.

In addition, the statements in this press 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.

ZYFLO CR(TM) is a trademark of Critical Therapeutics, Inc.

Geomatrix[R] is a registered trademark of SkyePharma PLC