Zyflo was first approved to treat asthma in the US in 1996. Critical Therapeutics acquired worldwide rights to the drug and other formulations of zileuton in late 2003 and early 2004. The company now expects the drug to be available to patients before the end of October 2005.
The drug is the only FDA approved asthma treatment that inhibits the production of 5-lipoxygenase (5-LO), the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms, including inflammation, swelling, broncho-constriction and mucus secretion.
The drug has a unique mechanism of action that works early in the inflammatory cascade, thus blocking a broad range of disease mediators.
“This approval of our lead product is a major step forward and positions us to generate top-line revenue growth,” said Dr Paul Rubin, president and CEO of Critical Therapeutics. “Zyflo’s unique mechanism of action provides another approach to manage severe persistent or difficult-to-treat asthma for patients who are not well controlled on usual care.”