Critical Therapeutics seeks approval for twice-daily asthma drug

Zileuton CR is an investigational drug for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. Critical Therapeutics currently markets its asthma drug, Zyflo (zileuton tablets), the immediate-release formulation of zileuton, in the US.

The new drug application (NDA) for zileuton CR includes results from two previously completed phase III clinical trials that evaluated the safety and efficacy of zileuton CR in 818 asthma patients. The NDA also includes results from three pharmacokinetic studies.

Pending FDA approval of the NDA, the company said that it expects to launch zileuton CR in the second half of 2007.

“Our NDA submission is a major milestone that moves us one-step closer to bringing zileuton CR to market,” said Frank Thomas, president of Critical Therapeutics. “We believe the twice-daily dosing regimen of zileuton CR will provide a more convenient option for patients than the current four-times-a-day dosing regimen of Zyflo and consequently should improve patient compliance and expand product use, if approved by the FDA.”

The controlled-release formulation of zileuton utilizes SkyePharma’s Geomatrix technology. Critical Therapeutics entered in to an agreement in December 2003 with SkyePharma, through its subsidiary Jagotec, under which SkyePharma would manufacture zileuton CR for clinical trials, regulatory review and commercial sale.