First twice-daily leukotriene synthesis inhibitor provides additional
treatment option for asthma patients not fully controlled on other
medications
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.
About ZYFLO CR and ZYFLO
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
http://www.zyflocr.com 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
http://www.zyflo.com 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 http://www.dey.com,
http://www.accuneb.com, http://www.curosurfusa.com,
http://www.cyanokit.com, http://www.duoneb.com, http://www.epipen.com and
http://www.perforomist.com. 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
or
Harriet Ullman
Feinstein Kean Healthcare
617-761-6776
hullman@fkhealth.com
SOURCE Dey, L.P.
 back to top
Related links:
http://www.dey.com
http://www.zyflocr.com http://www.zyflo.com
CONTACT:
Dey, L.P. Media Line, +1-800-755-5560 ext.
8363; or Harriet Ullman of Feinstein Kean Healthcare,
+1-617-761-6776, hullman@fkhealth.com
|
