Critical Therapeutics Announces FDA Approval of ZYFLO(R) for the Prevention and Chronic Treatment of Asthma
Wednesday September 28, 3:17 pm ET
Oral Drug Blocks the Production of Mediators That Can Trigger Asthma Symptoms
LEXINGTON, Mass.--(BUSINESS WIRE)--Sept. 28, 2005--Critical Therapeutics, Inc. (Nasdaq:CRTX - News) announced today that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) to manufacture and market ZYFLO® (zileuton tablets), which is indicated for the prevention and chronic treatment of asthma in patients 12 years of age and older. There were no material changes to the prescribing information insert for ZYFLO as a result of the FDA review. ZYFLO is expected to be available to patients before the end of October 2005.
ZYFLO 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, bronchoconstriction and mucus secretion. ZYFLO 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 Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "We have completed the build-out of an 80-person specialty sales force and will be initially calling on a targeted group of approximately 8,000-10,000 allergists, pulmonologists and other respiratory specialists. The message to this audience is simple: 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."
ZYFLO was first approved to treat asthma in the United States in 1996. Critical Therapeutics acquired worldwide rights to the drug and other formulations of zileuton in late 2003 and early 2004. In connection with the technology transfer and manufacturing of ZYFLO, Critical Therapeutics submitted an sNDA to the FDA on March 31, 2005 for approval of a new manufacturing process and new production sites.
"The U.S. Surgeon General recently declared that uncontrolled asthma is an under-recognized health problem that impacts millions of people," said Sally Wenzel, M.D., an investigator for ZYFLO and Professor of Medicine at the National Jewish Medical and Research Center in Denver who specializes in more severe forms of asthma. "Statistics suggest that of the approximately 20 million Americans with asthma, more than 11 million, or 55 percent, are not adequately controlling their symptoms. Based on the drug's pharmacologic profile, I believe ZYFLO may be an effective treatment for patients already taking beta agonists and high-dose steroids that have failed to sufficiently control their asthma symptoms."
About ZYFLO
ZYFLO is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO, which contains the active ingredient zileuton, blocks the formation of leukotrienes that may contribute to asthma symptoms. Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. The recommended dose is one 600mg tablet four times a day. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO can be continued during acute exacerbations of asthma.
Safety Information
Mild to moderate side effects associated with the use of ZYFLO are abdominal pain, upset stomach and nausea. A small percentage of patients treated with ZYFLO show an increased release of a liver enzyme known as ALT. As a result, the level of liver enzymes in patients treated with ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO and repeat the test on a regular basis while patients are on the medication.
For full prescribing information, please visit www.crtx.com/pat_pi.html.
About Critical Therapeutics
Critical Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to the asthma drug ZYFLO® (zileuton tablets), as well as other formulations of zileuton. Critical Therapeutics also is developing treatments directed toward the severe inflammatory response in acute diseases and conditions that lead to admission to the emergency room or intensive care unit, and acute exacerbations of other chronic diseases that frequently lead to hospitalization. For more information, please visitwww.crtx.com. |
