Critical Therapeutics, Inc. (CRTX) announced that the US Food and Drug Administration (FDA) has approved the company's New Drug Application (NDA) for twice-daily Zyflo CR(zileuton) extended-release tablets. Critical Therapeutics, together with its co-promotion partner Dey, L.P. (DEY), expects to begin marketing Zyflo CR in the US in the fall of 2007.
Zyflo CR and Zyflo (zileuton tablets) are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zyflo CR and Zyflo are not indicated for use in the reversal of bronchospasm in acute asthma attacks, but can be continued during acute exacerbations of asthma. Leukotrienes are inflammatory mediators in asthma that can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. Zyflo CR uses SkyePharma PLC's (LSE: SKP) proprietary Geomatrix drug delivery technology, which controls the amount and rate of drug released into the body.
"This approval is an exciting milestone for Critical Therapeutics because it solidifies our position in the asthma market and completes an important step to strengthen the Company and rebuild shareholder value," said Frank Thomas, Critical Therapeutics' president and chief executive officer. "Supported by our co-promotion partnership with DEY, I believe that Zyflo CR's twice daily dosing regimen will allow us to establish it as an important option in the asthma market and significantly expand our patient base."
"With its unique mechanism of action as a leukotriene synthesis inhibitor and its twice-daily dosing, Zyflo CR could effectively manage patients whose symptoms are not adequately controlled," said Sally Wenzel, M.D., an investigator for Zyflo CR and Zyflo and Professor at the University of Pittsburgh. "Despite available current asthma therapies, uncontrolled asthma still impacts a large number of Americans. Zyflo CR could potentially provide improved symptom control for those patients who still struggle day-to-day to control their asthma."
In March 2007, Critical Therapeutics and DEY, an affiliate of Germany-based Merck GKaA, entered into an agreement for the co-promotion of Zyflo CR and Zyflo, the immediate-release formulation of zileuton. DEY's 200-person sales force began promoting Zyflo on April 30, 2007. Upon the launch of Zyflo CR, the company and DEY's combined sales force of 240 representatives will begin promoting Zyflo CR to approximately 15,000 allergists, pulmonologists and primary care physicians across the US.
Zyflo CR and Zyflo are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zyflo CR and Zyflo are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with Zyflo CR and Zyflo can be continued during acute exacerbations of asthma.
The recommended dose of Zyflo CR is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. The recommended dose of Zyflo is one 600 mg immediate-release tablet four times a day for a total daily dose of 2400 mg.