CRITICAL THERAPEUTICS SUBMITS NDA FOR CONTROLLED-RELEASE ZILEUTON

Critical Therapeutics announced that it has submitted a new drug application (NDA) to the FDA for the twice-daily, controlled-release formulation of zileuton (zileuton CR). Zileuton CR is an investigational drug for the prevention and chronic treatment of asthma in adults and children 12 and older. Critical Therapeutics currently markets Zyflo (zileuton tablets), the immediate-release formulation of zileuton, in the United States.

The controlled-release formulation of zileuton utilizes SkyePharma PLC'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.