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Two Studies Support Efficacy of Critical Therapeutics' ZYFLO in Moderate to Severe Asthma Patients; Data Presented at the American Thoracic Society's 2005 International Conference

Posted on: Monday, 23 May 2005, 18:00 CDT

Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that scientific data were presented at the American Thoracic Society (ATS) 2005 International Conference supporting the clinical efficacy of ZYFLO(R) Filmtab(R) (zileuton tablets) in patients with moderate to severe asthma.

The data emanate from post-hoc analyses of pivotal trials of ZYFLO, which was approved by the U.S. Food and Drug Administration (FDA) in 1996 for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. In early 2004, Critical Therapeutics completed the acquisition of exclusive worldwide rights to ZYFLO and other formulations of zileuton.

The 2005 International Conference included poster presentations by Harold S. Nelson, M.D., professor of medicine at the National Jewish Medical and Research Center in Denver, and James P. Kemp, M.D., clinical professor of pediatrics at the University of California at San Diego. Highlights of their research are contained in abstracts published by the ATS.

Improvement of Asthma Symptoms

The data presented by Dr. Nelson and Dr. Kemp are from two double-blind, parallel, placebo-controlled, multi-center studies - involving a total of 774 patients - that established the efficacy of ZYFLO in the treatment of asthma. In Dr. Nelson's poster, data were presented from a post-hoc analysis of daily and nocturnal symptoms from study patients with moderate persistent (n=127) and severe persistent (n=117) asthma. He concluded that zileuton 600 mg administered four times per day (the approved dose) for 13 weeks "improves daily and nocturnal asthma symptoms and decreases the need for rescue medication in moderate and severe asthma patients." The response to treatment was greater for the severe persistent group, with statistically significant improvements observed in overall daily symptoms, overall nocturnal symptoms, rescue medication usage and individual symptoms such as cough, nasal congestion and shortness of breath. Lung function, as measured by FEV1, which ranged between 49.9 and 82.5 percent of normal at baseline, also improved.

Acute and Sustained Pulmonary Effects

In Dr. Kemp's poster presentation, the anti-inflammatory effects of zileuton 600 mg administered four times per day were compared with those of placebo 30, 60 and 120 minutes post-dose. In the zileuton group, rapid and sustained improvement in lung function was observed at every interval, Dr. Kemp concluded, "regardless of the degree of baseline asthma severity."

"We believe that ZYFLO has broad applicability to control symptoms and improve lung function of asthmatics with moderate to severe asthma. The post-hoc data presented by Dr. Kemp and Dr. Nelson support this position," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "This is significant because it represents the first published ZYFLO data specifically addressing the effects of the drug in moderate to severe asthma patients as defined by current NHLBI guidelines."

The ATS 2005 International Conference, held May 20-25 in San Diego, is the largest gathering of pulmonary and critical care specialists in the world. Abstracts of the posters presented by Dr. Kemp and Dr. Nelson are available by clicking on the "2005 Program /Abstract Search" link at http://www.thoracic.org/publications/abstracts.asp.

Critical Therapeutics plans to introduce ZYFLO in the fourth quarter of 2005, contingent upon regulatory approval of a supplemental New Drug Application (sNDA). Critical Therapeutics submitted an sNDA to the FDA in March 2005 to obtain regulatory approval for the change to the ZYFLO manufacturing process and transfer production of the drug to third-party sites.

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), 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

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 our drug development programs and related trials; the timing and success of regulatory approvals and product launches, including without limitation, the commercial launch of ZYFLO(R) tablets; the efficacy of our drug candidates; our strategy, future operations, plans and objectives of management; 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: conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; 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; the timing and success of submission, acceptance and approval of our regulatory filings, including, without limitation, the supplemental NDA for ZYFLO tablets, the NDA submission for the controlled-release formulation of zileuton and the IND filing for the IV 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 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. Filmtab(R) is a registered trademark of the Abbott Group of Companies.

Source: Business Wire

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