The company submitted the application in late July and, pending regulatory approval, expects to launch zileuton CR in the second half of 2007.
The new drug application includes results from two previously completed phase III trials that evaluated the safety and efficacy of zileuton in asthma patients. It also includes the results from two comparative bioavailability studies intended to bridge Critical Therapeutics’ formulation to the formulation used in the phase III trials.
Critical Therapeutics currently markets its asthma drug Zyflo, the immediate-release formulation of zileuton, in the US. Zyflo is the only 5-lipoxygenase inhibitor approved for marketing by the FDA.
“We expect zileuton to build on the market penetration of Zyflo and to enhance compliance by allowing patients to follow a more convenient and manageable twice daily dosing schedule,” said Critical Therapeutics’ president Frank Thomas.