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Skyepharma PLC - Twice daily ZYFLO CR(TM) (zileuton) extended-release tablets approved by the FDA for asthma |
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01 Jun 2007 |
Twice daily ZYFLO CR(TM) (zileuton) extended-release tablets approved by thh FDA for asthma
LONDON, UK | May 31, 2007 | SkyePharma PLC (LSE: SKP) today announcesthat the U.S. Food and Drug Administration (FDA) has approved CriticalTherapeutics, Inc.'s (Nasdaq: CRTX) New Drug Application (NDA) for twice-dailyZYFLO CR(TM) (zileuton) extended-release tablets. ZYFLO CR uses SkyePharma PLC'sproprietary Geomatrix(R) drug delivery technology, which controls the amount andrate of drug released into the body.
ZYFLO CR and ZYFLO(R) (zileuton tablets) are the only FDA-approved leukotrienesynthesis inhibitors for the prophylaxis and chronic treatment of asthma inadults and children 12 years of age and older. ZYFLO CR and ZYFLO are notindicated for use in the reversal of bronchospasm in acute asthma attacks, butcan be continued during acute exacerbations of asthma. Leukotrienes areinflammatory mediators in asthma that can trigger asthma symptoms, includinginflammation, swelling, bronchoconstriction and mucus secretion. CriticalTherapeutics expects to begin marketing ZYFLO CR in the U.S. together with itsco-promotion partner, Dey, L.P. (DEY) in the autumn of 2007.
Frank Condella, Chief Executive Officer of SkyePharma, said: 'The approval ofZYFLO CR is another successful application of our Geomatrix oralcontrolled-release technology. We continue our focus on oral and inhalationproducts as we build our business moving forward.'
Upon the launch of ZYFLO CR, Critical Therapeutics and DEY's combined salesforce of 240 representatives will begin promoting ZYFLO CR to approximately15,000 allergists, pulmonologists and primary care physicians across the U.S.SkyePharma will receive a high mid single digit royalty on sales of ZYFLO CR. For further information please contact:SkyePharma PLC
SOURCE: SkyePharma PLC |
