CRITICAL THERAPEUTICS (CRTX)
Approval Of ZYFLO CR the first extended -release leukotriene Synthesis Inhibitor For Asthma
The FDA approved Critical Therapeutics’ New Drug Application (NDA) for twice-daily ZYFLO CR™ (zileuton) extended-release tablets. 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. Critical Therapeutics, together with its co-promotion partner Dey, L.P. (DEY), expects to begin marketing ZYFLO CR in the U.S. in the fall of 2007.
Leukotrienes (whose synthesis the drug inhibits) are inflammatory mediators in asthma. They can trigger asthma symptoms, including inflammation, swelling, bronchoconstriction and mucus secretion. The drug is preventive and is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR and ZYFLO, however, can be continued during acute exacerbations of asthma.
ZYFLO CR uses SkyePharma PLC’s (SKP) proprietary Geomatrix® drug delivery technology, which controls the amount and rate of drug released into the body.
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.
ZYFLO CR and ZYFLO are contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal. A small percentage of patients treated with ZYFLO CR (2.5%) and ZYFLO (1.9%) in placebo-controlled trials showed an increased release of a liver enzyme known as ALT and bilirubin (an orange or yellowish pigment in bile). As a result, the level of liver enzymes in patients treated with ZYFLO CR and ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR and ZYFLO and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR and theophylline should reduce the theophylline dose by 50%. Patients taking ZYFLO CR and propranolol or warfarin should be monitored and doses adjusted as appropriate. Most common side effects associated with the use of ZYFLO CR and ZYFLO are sinusitis, nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea, respectively.
For full prescribing information for ZYFLO CR, please visit www.zyflocr.com or call the Company’s toll free telephone number 1-866-835-8216 to request medical information.
“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 U.S.
Critical Therapeutics, Inc. is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to two FDA-approved drugs for the prevention and chronic treatment of asthma in patients 12 years of age and older: twice-daily ZYFLO CR(TM) (zileuton) extended-release tablets and ZYFLO® (zileuton tablets). Critical Therapeutics is working to develop products for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is developing therapies directed toward the body’s inflammatory response. Critical Therapeutics is located in Lexington, Mass. For more information, please visit www.crtx.com.