London, UK--(Marketwire - May 31, 2007) -
TWICE DAILY ZYFLO CR(TM) (ZILEUTON) EXTENDED-RELEASE TABLETS APPROVED BY
THE FDA FOR ASTHMA
LONDON, UK, Thursday, May 31, 2007 - SkyePharma PLC (LSE: SKP) today
announces that the U.S. Food and Drug Administration (FDA) has approved
Critical Therapeutics, Inc.'s (Nasdaq:
CRTX) New Drug Application (NDA)
for twice-daily ZYFLO CR™ (zileuton) extended-release tablets. ZYFLO
CR uses SkyePharma PLC's proprietary Geomatrix® drug delivery
technology, which controls the amount and rate of drug released into the
body.
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. Critical Therapeutics
expects to begin marketing ZYFLO CR in the U.S. together with its co-
promotion partner, Dey, L.P. (DEY) in the autumn of 2007.
Frank Condella, Chief Executive Officer of SkyePharma, said: "The
approval of ZYFLO CR is another successful application of our Geomatrix
oral controlled-release technology. We continue our focus on oral and
inhalation products as we build our business moving forward."
Upon the launch of ZYFLO CR, Critical Therapeutics 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. SkyePharma will receive a high mid single
digit royalty on sales of ZYFLO CR.
For further information please contact:
SkyePharma PLC Frank Condella +44 20 7491 1777
Ken Cunningham
Peter Grant
Financial Dynamics (UK Enquiries) David Yates +44 20 7831 3113
Deborah Scott
Trout Group (US Enquiries) Christine Labaree +1 617 583 1308
Seth Lewis
About SkyePharma PLC
Using its proprietary drug delivery technologies, SkyePharma develops new
formulations of known molecules to provide a clinical advantage and life-
cycle extension. The Company has eleven approved products in the areas of
oral, inhalation and topical delivery that are marketed throughout the
world by leading pharmaceutical companies.
For more information, visit www.skyepharma.com
About ZYFLO CR and ZYFLO
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 CR 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 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 Critical Therapeutics at +1-866-835-8216 to
request medical information.
For full prescribing information for ZYFLO, please visit
www.zyflo.com or
call +1-866-835-8216 to request medical information.
ZYFLO® and ZYFLO CR™ are trademarks of Critical Therapeutics, Inc.
Geomatrix® is a registered trademark of SkyePharma PLC.
This information is provided by RNS
The company news service from the London Stock Exchange