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Every day receive the best plan of attack for the next day's trading directly from professional trader Kevin Haggerty.| Lewis O'neal | by www.tradingmarkets.com. All rights reserved. | 21.11 | 22:25 |
( | | | ) announced that the New Drug Application for its investigational drug, Zileuton - Controlled Release, for the prevention and chronic treatment of asthma in adults and children 12 years of age and older has been accepted for review by the U.S. Food and Drug Administration.
Critical Therapeutics submitted the New Drug Application or NDA for the twice-daily, controlled-release formulation of zileuton in late July. The company expects to launch the drug in the second half of 2007 on being approved by the FDA. The NDA includes results from previously completed Phase III trials that evaluated the safety and efficacy of zileuton - controlled release in 818 asthma patients.
The NDA also includes results from two comparative bioavailability studies intended to bridge Critical Therapeutics' formulation used in Phase III trials. The company currently markets its asthma drug ZYFLO, the immediate-release formulation of zileuton, in the U.S.
ZYFLO was approved in 1996 as an immediate-release, four times a day tablet for the chronic treatment of asthma and was launched in the US in 1997. According to the latest available information from the American Academy of Allergy Asthma and Immunology, more than 20 million people and nine million children under 18, in the US are diagnosed with asthma. There are approximately 5,000 deaths from asthma annually.
CRTX closed Friday's regular trade up 5.34% or $0.14 at $2.
76 on a volume of 47,744 shares.
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