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Published on 11/7/2005 in the Prospect News Biotech Daily.

Critical Therapeutics says Zyflo study shows improvement in asthma patients

By E. Janene Geiss

Philadelphia, Nov. 7 - Critical Therapeutics, Inc. said that results of a study show that asthma patients received comparable benefit from a low-dose inhaled corticosteroid when taken in combination with Zyflo compared to a higher dose of corticosteroid alone.

The results are based on a retrospective analysis of a multi-center safety and efficacy study of patients with asthma and presented Monday at the American College of Allergy, Asthma & Immunology's annual meeting, according to a company news release.

The lung function and symptoms of patients taking the prescribed dose of zileuton plus beclomethasone dipropionate (BDP) at 200 µg twice daily was compared with that of patients taking BDP at 400 µg twice daily.

When administered in combination, the severe persistent group of patients showed comparable improvements in lung function compared to those patients taking the higher dose of BDP as a monotherapy. Officials said severe persistent patients taking the combination therapy also showed a greater reduction in their use of rescue medication.

"These data are particularly exciting because they suggest that zileuton has the potential to provide benefit to patients already on a low dose of BDP," Paul Rubin, president and chief executive officer, said in the release.

Zyflo is indicated for the prevention and chronic treatment of asthma in adults and children 12 and older. It is the only drug in the class of 5-lipoxygenase inhibitors approved for marketing by the FDA.

Critical Therapeutics is a biopharmaceutical company based in Lexington, Mass.


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