New Formulation Provides Powerful Relief Of Seasonal Allergy Symptoms,
Including Nasal Congestion
KENILWORTH, N.J., Feb. 1 /PRNewswire/ -- Schering-Plough Corporation
(NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA)
has approved CLARINEX-D(R) 12 HOUR (desloratadine 2.5 mg and pseudoephedrine
sulfate, USP 120 mg) Extended Release Tablets for the relief of nasal and non-
nasal symptoms of seasonal allergic rhinitis (outdoor allergies), including
nasal congestion, in patients 12 years of age and older.
CLARINEX-D 12 HOUR will be available nationwide in March 2006, in time for
the spring allergy season. The new treatment option addresses an important
need for allergy sufferers, who indicate that nasal congestion is the most
bothersome symptom of allergic rhinitis.(1) In addition, a survey of 1,000
adults with allergic rhinitis found nearly 85 percent experience nasal
congestion when they first wake up, making it the most prevalent allergy
symptom in the morning.(2)
"For my patients who report nasal congestion along with other allergy
symptoms, an antihistamine and decongestant combination treatment provides
safe and effective relief," said William Lumry, M.D., Allergy & Asthma
Specialists, Dallas, Texas. "With CLARINEX-D 12 or 24 hour extended release
tablets, I can now prescribe a 12- or 24-hour formulation that does not cause
drowsiness and treats their nasal blockage effectively."
The new formulation uses a bi-layer tablet delivery system, which controls
the release of the pseudoephedrine component for consistent delivery. The
recommended twice-daily dosing of CLARINEX-D 12 HOUR will help patients
control their nasal congestion, along with their sneezing, runny nose, itchy
throat, or itchy and watery eyes, in the morning and throughout the day.
"Physicians now have a 12-hour formulation that combines the proven
efficacy and safety of CLARINEX with an established decongestant," said Robert
J. Spiegel, M.D., chief medical officer and senior vice president,
Schering-Plough. "CLARINEX-D 12 HOUR provides physicians with another option
for tailoring allergy treatment regimens based on patients' specific symptoms
and needs."
The FDA approved CLARINEX-D 12 HOUR based on results from two clinical
trials involving 1,248 patients 12 to 78 years of age with seasonal allergic
rhinitis, 414 of whom received CLARINEX-D 12 HOUR. In both 2-week randomized,
parallel group trials, the antihistaminic efficacy of CLARINEX-D 12 HOUR, when
examining symptoms of allergic rhinitis excluding nasal congestion, was
significantly greater than that of pseudoephedrine alone during the treatment
period. And the decongestant efficacy of CLARINEX-D 12 HOUR was significantly
greater than that of desloratadine alone during the treatment period, based on
nasal congestion scores. As the data show, CLARINEX-D 12 HOUR effectively
treats nasal congestion, the most bothersome symptom of allergic rhinitis, in
addition to relieving other nasal and non-nasal symptoms of allergic rhinitis.
The most commonly reported adverse events for CLARINEX-D 12 HOUR Extended
Release Tablets compared with pseudoephedrine are insomnia (10% vs. 13%),
headache (8% vs. 9%), dry mouth (8% vs. 8%), fatigue (4% vs. 2%), somnolence
(3% vs. 2%), and pharyngitis (3% vs. 3%).
CLARINEX-D 12 HOUR Extended Release Tablets should be administered when
the antihistaminic properties of desloratadine and the nasal decongestant
properties of pseudoephedrine are desired.
About Allergies
Seasonal allergies affect an estimated 36 million people in the U.S.
Symptoms, which include sneezing, runny nose, congestion, itchy throat, or
itchy and watery eyes, can have a significant impact on everyday activities at
work, school and leisure time.(3) There also is a growing body of evidence
that points to an association between allergies and more serious conditions,
such as asthma.(4)
About the CLARINEX Family of Products
CLARINEX is the only branded prescription allergy treatment available in
this diverse variety of formulations. CLARINEX(R) (5 mg) Tablets treat the
symptoms of seasonal and year-round allergies and hives of unknown cause in
patients 12 years of age and older. CLARINEX (2.5 orally-disintegrating
tablets) RediTabs(R) tablets treat the symptoms of seasonal and year-round
allergies and hives of unknown cause in patients 6 years of age and older; a
5mg RediTabs tablet is available for patients 12 years and older. CLARINEX
(0.5 mg per 1 mL) Syrup, available in a bubblegum flavor, is approved for the
relief of symptoms of outdoor allergies in children 2 years and older, and
indoor allergies and hives of unknown cause in children as young as 6
months.(5) CLARINEX-D(R) 24 HOUR (desloratadine 5 mg/ pseudoephedrine 240 mg)
Extended Release Tablets is a once-daily prescription antihistamine and
decongestant combination treatment which provides 24-hour relief of nasal and
non-nasal symptoms of outdoor allergies in patients 12 years of age and
older.(6)
CLARINEX Tablet side effects in patients 12 years of age and older with
seasonal and year-round allergies were similar to placebo and included sore
throat, dry mouth and fatigue. Tablet side effects in patients 12 years of
age and older with ongoing itching and rash from hives of unknown cause were
headache, nausea and fatigue. Syrup side effects in children 6 to 11 years of
age were similar to placebo. For children 6 months to 5 years of age, syrup
side effects varied by age and included fever, diarrhea, upper respiratory
infection, irritability and coughing.(5)
Due to its pseudoephedrine component, CLARINEX-D 12 HOUR Extended Release
Tablets and CLARINEX-D 24 HOUR Extended Release Tablets should not be taken by
patients with narrow-angle glaucoma (abnormally high eye pressure), difficulty
urinating, severe high blood pressure, or severe heart disease, or by patients
who have taken a monoamine oxidase (MAO) inhibitor within the past 14 days.
Patients with high blood pressure; diabetes; heart disease; increased
intraocular pressure (eye pressure); thyroid, liver or kidney problems; or
enlarged prostate should check with their health care provider before taking
CLARINEX-D 12 HOUR Extended Release Tablets or CLARINEX-D 24 HOUR Extended
Release Tablets. Care should be used if CLARINEX-D 12 HOUR Extended Release
Tablets or CLARINEX-D 24 HOUR Extended Release Tablets are taken with other
antihistamines or decongestants because combined effects on the cardiovascular
system may be harmful. The most commonly reported adverse events for
CLARINEX-D 24 HOUR Extended Release Tablets were dry mouth, headache,
insomnia, fatigue, sore throat and drowsiness.(6,7)
Visit http://www.CLARINEX.com for more information on preventing and
treating seasonal nasal allergies. For additional important safety
information, full prescribing information is available at:
http://www.spfiles.com/piclarinex.pdf.
About Schering-Plough Corporation
Schering-Plough is a global science-based health care company with leading
prescription, consumer and animal health products. Through internal research
and collaborations with partners Schering-Plough discovers, develops,
manufactures and markets advanced drug therapies to meet important medical
needs. Schering-Plough's vision is to earn the trust of the physicians,
patients and customers served by its more than 30,000 people around the world.
The company is based in Kenilworth, N.J., and its Web site is
http://www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release
includes certain "forward-looking statements" within the meaning of the
Securities Litigation Reform Act of 1995, including statements related to
CLARINEX and the potential market for CLARINEX. Forward-looking statements
relate to expectations or forecasts of future events. Schering-Plough does
not assume the obligation to update any forward-looking statements. Many
factors could cause actual results to differ materially from Schering-Plough's
forward-looking statements, including market forces, economic factors, product
availability, current and future branded, generic or over-the-counter
competition and the regulatory process, among other uncertainties. For
further details about these or other factors that may impact the forward-
looking statements, see Schering-Plough's Securities and Exchange Commission
filings, including the company's third quarter 2005 10-Q.
References:
1. Roper Public Affairs and Media. Impact of nasal congestion among
allergic rhinitis sufferers, 2004.
2. Roper Public Affairs and Media. Assessment of morning allergy suffering
among adults with allergies, 2005.
3. The American Academy of Allergy, Asthma & Immunology, Inc., The Allergy
Report, 2000.
4. Linneberg A, Henrik Nielsen N, Frolund L, et al. The link between
allergic rhinitis and allergic asthma: a prospective population-based
study. The Copenhagen Allergy Study,. Allergy 2002; 57: 1048-52.
5. CLARINEX(R) Tablets, Syrup and RediTabs Product Information. Schering
Corporation.
6. CLARINEX-D(R) 24 HOUR Product Information. Schering Corporation.
7. CLARINEX-D(R) 12 HOUR Product Information. Schering Corporation.
SOURCE Schering-Plough Corporation
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