>>LEXINGTON, Mass.--(BUSINESS WIRE)--May 23, 2005--Critical Therapeutics, Inc. (Nasdaq: CRTX - News) today announced that scientific data were presented at the American Thoracic Society (ATS) 2005 International Conference supporting the clinical efficacy of ZYFLO® Filmtab® (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 thoracic.org.
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.<<
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Though launch is a bit behind the original target of 1H05, we're still looking at July 2nd for the 3 month mark of the FDA review of the sNDA. If CRTX gets whacked due to this financing and summer doldrums, could be worth a flyer. Though I haven't paid attention to see how they plan to launch. Aside from the financing, I haven't noticed any PRs concerning the impending marketing effort. Maybe we should listen to a recent webcast.
PS Hey Michael, how about getting this transferred to a biotech board?
Cheers, Tuck |
