Zileuton Shows Significant Benefit in Prevention and Chronic Treatment of Asthma
Apr 2, 2005 - 8:38:38 AM
Critical Therapeutics, Inc. (Nasdaq: CRTX), today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the Company's investigational asthma drug ZYFLO(R) Filmtab(R) (zileuton tablets). Approval of the sNDA would allow Critical Therapeutics to begin marketing its version of ZYFLO in the United States.
"This is an exciting event that moves us one step closer toward our goal of becoming a fully integrated biopharmaceutical company," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "We anticipate launching ZYFLO in the second half of 2005, contingent upon regulatory approval of our sNDA."
The FDA approved ZYFLO in 1996 for the prevention and chronic treatment of asthma in patients 12 years of age and older. Critical Therapeutics in-licensed worldwide rights to ZYFLO in March 2004 and to other formulations of zileuton for a range of inflammatory diseases and conditions in December 2003.
ZYFLO has been commercially unavailable since early 2004 when commercial supply was depleted. Critical Therapeutics is required to submit an sNDA for ZYFLO because it is changing the manufacturing process and transferring production of the zileuton active pharmaceutical ingredient and the tablet formulation to third-party sites.
"ZYFLO is the only asthma treatment that blocks the activity of the enzyme responsible for producing an array of inflammatory mediators, most notably leukotrienes," Dr. Rubin said. "We believe this novel mechanism will allow ZYFLO to occupy a unique position in the treatment of asthma."
Clinical supply of ZYFLO currently is available through an open-label Phase IIIb study for patients who previously used and benefited from ZYFLO and need it to control their asthma symptoms. For more information regarding the open-label study, please visit the related link.
ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. For full prescribing information, please visit the related link.
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