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).
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