Dey and Critical Theraputics launch Zyflo in U.S.

LEXINGTON, Mass. Dey and Critical Therapeutics have begun launching Zyflo CR nationwide. The drug is an extended release version of Zyflo and is a twice daily medication for the prevention and chronic treatment of asthma in patients 12 years of age and older.

The 2007 Guidelines for the Diagnosis and Management of Asthma, which were developed by the National Asthma Education and Prevention Program, recommended zileuton, (Zyflo) as a therapeutic alternative for patients as part of a step-approach to reducing asthma symptoms and preventing exacerbations.

“We are excited that we are now able to offer doctors and their patients a twice-daily dosing regimen with a similar safety profile as Zyflo (zileuton tablets), our four-times-daily immediate-release formulation,” said Frank Thomas, president and chief executive officer of Critical Therapeutics. “While asthma prevalence continues to rise, we are pleased that we can offer an asthma treatment with a unique mechanism of action. Zyflo and Zyflo CR are the only leukotriene synthesis inhibitors approved by the U.S. Food and Drug Administration (FDA). Zyflo has already helped many patients better control their asthma symptoms and we look forward to seeing those positive outcomes continue as we bring Zyflo CR to market.”

According to Critical Therapeutics, asthma affects about 20 million Americans.