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Critical Therapeutics Announces the Publication of Data for ZyfloCR,(Zileuton) Extended-Release Tablets in the Journal of Asthma

ith placebo plus usual care (n=307) in 926 patients with moderate asthma. The adverse event profile was similar in the two treatment groups. Eleven patients (1.8%) receiving ZYFLO CR and two patients (0.7%) receiving placebo experienced elevations of ALT greater than or equal to 3x the upper limit of normal (ULN). These elevations typically occurred (81.8%) during the first three months of exposure and most resolved within 21 days after discontinuation.

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 t
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