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Twice-Daily Leukotriene Synthesis Inhibitor Now Available

NAPA, Calif., Sept. 27 /PRNewswire-FirstCall/ -- Dey, L.P., an affiliate of Merck KGaA of Darmstadt, Germany, announced today that it has launched zileuton (Zyflo CR) extended-release tablets with its marketing partner, Critical Therapeutics. Zyflo CR offers twice-daily, extended-release dosing for the prevention and chronic treatment of asthma in patients 12 years of age and older.

"We are excited to partner with Critical Therapeutics to bring a twice-daily formulation of Zyflo CR (zileuton tablets) to the many patients affected by chronic asthma," said Christy Taylor, Executive Vice President, Sales, Marketing and Business Development at DEY. "Our collaboration with Critical Therapeutics and the launch of Zyflo CR demonstrate our commitment to developing and marketing innovative respiratory therapeutics to enhance patients' lives."

In March 2007, Critical Therapeutics and DEY entered into an agreement for the co-promotion of Zyflo CR and Zyflo CR, the immediate-release formulation of zileuton. DEY's sales force began promoting ZYFLO(R) on April 30, 2007. Zyflo CR received approval from the U.S. Food and Drug Administration on May 31, 2007.

About Zyflo CR and Zyflo

Zyflo CR and Zyflo (zileuton tablets) 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, but can be continued during acute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. Zyflo CR uses SkyePharma PLC's 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(R) should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR(TM) and ZYFLO(R) and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR(TM) and theophylline should reduce the theophylline dose by 50%. Patients taking ZYFLO CR(TM) and propranolol or warfarin should be monitored and doses adjusted as appropriate. Most common side effects associated with the use of ZYFLO CR(TM) and ZYFLO(R) are sinusitis, nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea, respectively.

Source: Dey

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