FDA Approves ZYFLO CR Extended-Release Tablets For Critical Therapeutics
U.S. Food and Drug Administration has approved the New Drug Application of Critical Therapeutics for ZYFLO CR extended-release tablets.
ZYFLO CR offers twice-daily, extended-release dosing. Under a co-promotion agreement executed between the two companies in March 2007, DEY will co-market Critical Therapeutics' ZYFLO CR.
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.
"We applaud our marketing partner's success in securing FDA approval of the only twice-daily leukotriene synthesis inhibitor for asthma," said Mel Engle, President and CEO of DEY. "ZYFLO CR has a unique mechanism of action that, combined with its twice-daily dosing regimen, could fundamentally expand and improve the treatment options available to asthma patients. We are delighted to participate in commercializing Critical Therapeutics' ZYFLO CR, which will continue to expand DEY's presence in asthma and respiratory care."
In March 2007, Critical Therapeutics and DEY entered into an agreement for the co-promotion of ZYFLO CR and ZYFLO, the immediate-release formulation of zileuton. DEY's sales force began promoting ZYFLO on April 30, 2007. Upon the launch of ZYFLO CR, the combined sales forces of the two companies will begin promoting ZYFLO CR to approximately 15,000 allergists, pulmonologists and primary care physicians across the U.S.
ZYFLO CR and ZYFLO are the only FDA-approved leukotrienes 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.
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 by50%. 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.