FDA clears Critical Therapeutics asthma drug

Critical Therapeutics, together with its co-promotion partner Dey, said that it expects to begin marketing Zyflo CR in the US in the fall of 2007.

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. Leukotrienes are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion.

Zyflo CR uses SkyePharma’s Geomatrix drug delivery technology, which controls the amount and rate of drug released into the body.

Frank Thomas, Critical Therapeutics’ president and CEO, said: “Supported by our co-promotion partnership with Dey, I believe that Zyflo CR’s twice daily dosing regimen will allow us to establish it as an important option in the asthma market and significantly expand our patient base.”

In March 2007, Critical Therapeutics and Dey, an affiliate of Germany-based Merck KGaA, entered into an agreement for the co-promotion of Zyflo CR and Zyflo, the immediate-release formulation of zileuton.