Navigation Links
Dey L.P. and Critical Therapeutics Launch Twice-Daily ZYFLO CR(TM) (Zileuton) Extended-Release Tablets for the Chronic Treatment of Asthma

First twice-daily leukotriene synthesis inhibitor provides additional

treatment option for asthma patients not fully controlled on other


NAPA, Calif., Sept. 27 /PRNewswire-FirstCall/ -- Dey, L.P., an affiliate of Merck KGaA of Darmstadt, Germany, announced today that it has launched ZYFLO CR(TM) (zileuton) extended-release tablets with its marketing partner, Critical Therapeutics, Inc. (Nasdaq: CRTX). ZYFLO CR(TM) offers twice-daily, extended-release dosing for the prevention and chronic treatment of asthma in patients 12 years of age and older.

"We are excited to partner with Critical Therapeutics to bring a twice-daily formulation of ZYFLO(R) (zileuton tablets) to the many patients affected by chronic asthma," said Christy Taylor, Executive Vice President, Sales, Marketing and Business Development at DEY. "Our collaboration with Critical Therapeutics and the launch of ZYFLO CR(TM) demonstrate our commitment to developing and marketing innovative respiratory therapeutics to enhance patients' lives."

In March 2007, Critical Therapeutics and DEY entered into an agreement for the co-promotion of ZYFLO CR(TM) and ZYFLO(R), the immediate-release formulation of zileuton. DEY's sales force began promoting ZYFLO(R) on April 30, 2007. ZYFLO CR(TM) received approval from the U.S. Food and Drug Administration on May 31, 2007.


ZYFLO CR(TM) and ZYFLO(R) (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(TM) and ZYFLO(R) 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(TM) uses SkyePharma PLC's (LSE: SKP) proprietary Geomatrix(R) drug delivery technology, which controls the amount and rate of drug released into the body.

The recommended dose of ZYFLO CR(TM) 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(R) is one 600 mg immediate-release tablet four times a day for a total daily dose of 2400 mg.

ZYFLO CR(TM) and ZYFLO(R) 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(TM) (2.5%) and ZYFLO(R) (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(TM) and ZYFLO(R) should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR(TM) and ZYFLO(R) and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR(TM) and theophylline should reduce the theophylline dose by 50%. Patients taking ZYFLO CR(TM) and propranolol or warfarin should be monitored and doses adjusted as appropriate. Most common side effects associated with the use of ZYFLO CR(TM) and ZYFLO(R) are sinusitis, nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea, respectively.

For full prescribing information for ZYFLO CR(TM), please visit or call the Company's toll free telephone number 1-866-835-8216 to request medical information.

For full prescribing information for ZYFLO(R), please visit or call the Company's toll free telephone number 1-866-835-8216 to request medical information.

About Dey, L.P.

Dey, L.P. is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases, respiratory-related allergies, and emergency care medicine. As the US leader in nebulized respiratory medication, DEY puts patients first through its development of innovative and affordable therapies. The Web sites for DEY include,,,,, and Dey, L.P. is an affiliate of Merck KGaA, Darmstadt, Germany.

ZYFLO is a registered trademark of Critical Therapeutics, Inc.

ZYFLO CR is a trademark of Critical Therapeutics, Inc.

GEOMATRIX is a registered trademark of SkyePharma PLC.

Media contacts: Dey, L.P. Media Line

1-800-755-5560 ext. 8363


Harriet Ullman

Feinstein Kean Healthcare


Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Critical factors for successful microarray and real-time PCR analyses
2. MicroRNA Profiling by Array Analysis Reveals Critical BioMarkers
3. Chicago-Milwaukee "mega-metro" infrastructure improvements are critical
4. Caden Biosciences may signal critical mass
5. IT critical in pandemic response, but many are not paying attention
6. IT is critical for economic growth, says UW business dean
7. JohnLets Get Serious - Manufacturing is a critical part of the Wisconsin economy
8. Diamond Film May Enable Critical New Sensors For Bioterror
9. Canadian firm buys Proventiv Therapeutics, makes ex-Bone Care exec CEO
10. Merge launches diagnostic mammography workstation in Europe
11. Einstein Wireless launches cellular alert system
Post Your Comments:
(Date:11/24/2015)... Nov. 24, 2015 Halozyme Therapeutics, Inc. (NASDAQ: HALO ... New York on Wednesday, December 2 at ... , president and CEO, will provide a corporate overview. ... at 1:00 p.m. ET/10:00 a.m. PT . ... will provide a corporate overview. --> th Annual ...
(Date:11/24/2015)... 24, 2015  Clintrax Global, Inc., a worldwide provider of clinical ... today announced that the company has set a new quarterly earnings ... on quarter growth posted for Q3 of 2014 to Q3 of ... Mexico , with the establishment of an ... --> United Kingdom and Mexico ...
(Date:11/24/2015)... , November 24, 2015 ... recent market research report released by Transparency Market Research, ... expand at a CAGR of 17.5% during the period ... Testing Market - Global Industry Analysis, Size, Volume, Share, ... global non-invasive prenatal testing market to reach a valuation ...
(Date:11/24/2015)... ... 2015 , ... InSphero AG, the leading supplier of easy-to-use solutions for production, ... to serve as Chief Operating Officer. , Having joined InSphero in November ... and was promoted to Head of InSphero Diagnostics in 2014. There she has ...
Breaking Biology Technology:
(Date:11/17/2015)... , November 17, 2015 ... au 19 novembre  2015.  --> Paris ... --> DERMALOG, le leader de l,innovation biométrique, ... la fois passeports et empreintes sur la même surface ... les passeports et l,autre pour les empreintes digitales. Désormais, ...
(Date:11/12/2015)... BOSTON , Nov. 12, 2015  A golden ... for Duchenne muscular dystrophy (DMD) has provided a new ... Boston Children,s Hospital, the Broad Institute of MIT and ... Brazil . Cell, ... some dogs "escape" the disease,s effects. The Boston Children,s ...
(Date:11/10/2015)...  In this report, the biomarkers market ... type, application, disease indication, and geography. The ... consumables, services, software. The type segments included ... biomarkers, and validation biomarkers. The applications segments ... drug discovery and development, personalized medicine, disease ...
Breaking Biology News(10 mins):