Sanofi-aventis
announced the U.S. Food and Drug Administration (FDA) has approved
Nasacort AQ Nasal Spray (triamcinolone acetonide) for children aged 2 - 5
years old for the treatment of nasal symptoms associated with seasonal and
perennial allergic rhinitis.
The FDA based its approval on the results of a multicenter, randomized,
double-blind, placebo-controlled study demonstrating that Nasacort AQ can
be used safely and effectively to treat nasal symptoms of year-round
allergies in children between two and five years. This is the first and
largest placebo- controlled trial designed to specifically investigate both
the efficacy and safety of an intranasal corticosteroid vs. placebo in 2-5
years of age group.
"We welcome this new treatment option for our very young patients,"
said lead investigator Dr. Steven Weinstein, Director, Allergy and Asthma
Specialist Medical Group in Huntington Beach, California. "Nasacort AQ
Nasal Spray has been proven effective for the age groups two to five years
to relieve nasal allergy symptoms."
Approval Based on Pediatric Clinical Trial
The study showed that Nasacort AQ, given as 1 spray/nostril once daily
for four weeks to children aged 2-5 years, with year-round allergic
rhinitis diagnosed for at least one year, significantly improved the
combined symptoms of sneezing, itching, runny nose and congestion, compared
with placebo.
A total of 464 patients were randomized and received either Nasacort AQ
or placebo as 1 spray per nostril once daily for 4 weeks. To participate in
the study, patients had to have year-round allergic rhinitis diagnosed for
at least one year and reported sufficiently severe symptoms of nasal
stuffiness, discharge and sneezing.
Every morning, caregivers were asked to rate his/her child’s symptoms
of sneezing and nasal stuffiness, discharge and itching over the last 24
hours. Patients’ symptoms were also rated at the time immediately before
receiving their daily medication.
Over four weeks, patients treated with Nasacort AQ showed a reduction
from baseline in the mean adjusted sum of symptoms including sneezing,
nasal stuffiness, discharge and itching (Total Nasal Symptom Score or TNSS)
measured over the last 24 hours (reflective TNSS) and immediately prior to
dosing (instantaneous TNSS). Instantaneous TNSS was the primary end point
and showed a greater reduction from baseline of -2.28 +/- 0.16 and -1.92
+/- 0.16 in the Nasacort AQ and placebo groups respectively trending in
favor of Nasacort AQ (p value 0.095). Reflective TNSS showed a
statistically significantly greater reduction from baseline in the Nasacort
AQ group -2.31 +/- 0.15 vs. placebo - 1.87 +/- 0.15 (p value 0.0328). The
rates of the treatment-emergent adverse events (TEAEs) among patents
treated with Nasacort were comparable to those given placebo (50.8% and
48.3% respectively). The most common TEAEs observed during the double-blind
portion of the trial included cough (7.6% vs 9.2%), pyrexia (6.8% vs 8.0%),
and headache (5.5% vs 4.2%) in the Nasacort AQ vs placebo groups
respectively. No serious side effects were reported in either group. There
were no clinically meaningful changes in any of the vital signs analyzed.
About Allergic Rhinitis
Allergic rhinitis is an allergic condition usually accompanied by
sneezing, watery nasal discharge and itching of the nose and eyes. Caused
by an allergic reaction to allergens such as house dust mites, animal
dander, tree or grass pollen, allergic rhinitis is the most common chronic
childhood disease, effecting as many as 40% of all children in the U.S. On
any given day, 10,000 American children miss school because of allergic
rhinitis, for a total of 2 million lost school days.
About Sanofi Aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
Forward Looking Statements
This press release contains forward-looking statements as defined in
the generic levitra online buy Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical facts.
These statements include product development, product potential projections
and estimates and their underlying assumptions, statements regarding plans,
objectives, intentions and expectations with respect to future events,
operations, products and services, and statements regarding future
performance. Forward- looking statements are generally identified by the
words "expects," "anticipates," "believes," "intends," "estimates," "plans"
and similar expressions. Although sanofi-aventis’ management believes that
the expectations reflected in such forward-looking statements are
reasonable, investors are cautioned that forward-looking information and
statements are subject to various risks and uncertainties, many of which
are difficult to predict and generally beyond the control of
sanofi-aventis, that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and uncertainties
include among other things, the uncertainties inherent in research and
development, future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMEA, regarding
whether and when to approve any drug, device or biological application that
may be filed for any such product candidates as well as their decisions
regarding labelling and other matters that could affect the availability or
commercial potential of such products candidates, the absence of guarantee
that the products candidates if approved will be commercially successful,
the future approval and commercial success of therapeutic alternatives as
well as those discussed or identified in the public filings with the SEC
and the AMF made by sanofi-aventis, including those listed under "Risk
Factors" and "Cautionary Statement Regarding Forward- Looking Statements"
in sanofi-aventis’ annual report on Form 20-F for the year ended December
31, 2007. Other than as required by applicable law, sanofi- aventis does
not undertake any obligation to update or revise any forward- looking
information or statements.
Sanofi Aventis

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