BRISTOL, TN -- 09/10/08 --
Fall has arrived, and for one in five children,
that means it is eczema season. Eczema, also known as atopic dermatitis
(AD), is a chronic skin condition that causes itching, rash, scaliness,
redness, inflammation, weeping and crusting of the skin.
"Atopic dermatitis can occur at any time of year, and for some patients,
unfortunately, it is a year-round problem," said Dr. Mark Boguniewicz,
pediatric allergist-immunologist at the National Jewish Medical and
Research Center in Denver, Colorado. "However, for most patients, it is
typically worse in the cold, dry months of fall and winter."
This condition appears most frequently on the hands and face, and one of
the biggest challenges is dealing with the intense itching. Itch is
especially troubling for infants and children, who become irritable and
uncomfortable.
According to Dr. Boguniewicz, "Atopic dermatitis is much more than an itchy
rash. These children often scratch to the point of bleeding. Their itching
interferes with other activities, most importantly sleep."
AD flare-ups are usually treated with topical steroid creams, but many
parents are concerned about using steroids on their children for extended
periods.(1) A recently published study in the June issue of The Journal of
Pediatrics showed that Atopiclair® nonsteroidal cream is safe and
effective as a monotherapy for the treatment of symptoms of mild to
moderate atopic dermatitis in infants and children.(2)
"This study shows that Atopiclair improves the symptoms and appearance of
eczema in children and infants. The fast improvement in itch will be
particularly important to patients and their families. Steroid-sparing
therapies are especially useful when treating children with this chronic,
relapsing condition and so we were pleased that patients using Atopiclair
in this study had significantly less need for steroid creams," said Dr.
Boguniewicz, the lead investigator of the study.
The 43-day study was conducted in multiple US centers, and involved 142
patients (age 6 months to 12 years), treated 3 times a day with either
Atopiclair or vehicle base cream. Rapid resolution of itch was demonstrated
by a 37% improvement in mean itch score by day 3. Dramatic improvement in
itch from baseline continued through the study in the Atopiclair group,
reaching 78% by day 43. By day 22, investigators rated 77% of patients
treated with Atopiclair as "clear" or "almost clear" of mild to moderate
symptoms that were present on day 1.(2)
The most commonly reported adverse events in the study were stinging (8%),
burning (7%), and fever (7%) in the Atopiclair group and upper respiratory
infections (9%), burning (7%), fever (7%), and colds (7%) in the vehicle
group.(1) The percentage of adverse events judged by investigators to be
related to the study medication was 17% in the Atopiclair group and 13% in
the vehicle group. Adverse events led to discontinuation in 10% of those
treated with Atopiclair and 16% of those treated with vehicle.
About Atopic Dermatitis
Approximately 17% of school-aged children in the United States have AD, a
chronically relapsing skin disorder.(3) AD is characterized by a number of
complex skin abnormalities and its management commonly requires numerous
treatment modalities.(2) Symptoms and sleep disruptions caused by the
disease can negatively impact quality of life for patients and their
families.
About Atopiclair
Atopiclair Nonsteroidal Cream is available by prescription only. Atopiclair
contains powerful moisturizers and key lipids that help maintain a healthy
skin barrier while providing relief of itching and other symptoms
associated with AD. Atopiclair has no restriction on duration of use and
has been studied in children as young as 1 month of age.(4) Atopiclair
provides physicians with a much needed, steroid-free option for the
long-term treatment of AD, alone or in combination with other therapies.
Atopiclair may be particularly useful in pediatric patients because they
may face increased risk of adverse events associated with steroids.(5)
Under the supervision of a health care professional, Atopiclair
nonsteroidal cream is indicated to manage and relieve the itching, burning,
and pain experienced with various types of dermatoses, including atopic
dermatitis and allergic contact dermatitis. Atopiclair nonsteroidal cream
helps to relieve dry, waxy skin by maintaining a moist skin environment,
which is beneficial to the healing process.
Atopiclair nonsteroidal cream does not contain milk, wheat, peanut or
animal derivatives. Atopiclair nonsteroidal cream does contain shea butter
(Butyrospermum parkii), a derivative of shea nut oil (not peanut oil).
Patients with a known allergy to nuts or nut oils should consult their
physician before using this topical preparation. For external use only;
avoid contact with eyes.
Atopiclair is manufactured under license from Sinclair Pharmaceuticals Ltd.
Please visit www.atopiclairUS.com to request additional information,
including the full US Prescribing Information.
About Graceway Pharmaceuticals, LLC
Graceway Pharmaceuticals, LLC ("Graceway"), headquartered in Bristol, TN,
is a pharmaceutical company focused on acquiring, in-licensing, and
developing branded prescription pharmaceutical products. Current
prescription products marketed by Graceway include Aldara® (imiquimod)
Cream, 5%, Maxair® Autohaler® (pirbuterol acetate inhalation aerosol),
Atopiclair® Nonsteroidal Cream, and Estrasorb® (estradiol topical
emulsion). Aldara®, Maxair® Autohaler®, Atopiclair®and Estrasorb®
are trademarks owned by or licensed to Graceway. For more information on
Graceway's products, including Important Safety Information, please visit
www.gracewaypharma.com. To download video in seven formats please visit
http://newsinfusion.com/video_details.php?videoId=219.
References:
(1.) Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the
management of atopic dermatitis. J Allergy Clin Immunol.
2006;118(1):226-232.
(2.) Boguniewicz M, Zeichner JA, Eichenfield LF, et al. MAS063DP is
effective monotherapy for mild to moderate atopic dermatitis in infants and
children: a multicenter, randomized, vehicle-controlled study. J Pediatr.
2008;152(6):854-859.
(3.) Laughter D, Istvan JA, Tofte SJ, Hanifin JM. The prevalence of atopic
dermatitis in Oregon schoolchildren. J Am Acad Dermatol.
2000;43(4):649-655.
(4.) Data on file. Graceway Pharmaceuticals, LLC.
(5.) Callen J, Chamlin S, Eichenfield LF, et al. A systematic review of the
safety of topical therapies for atopic dermatitis. Br J Dermatol.
2007;156(2):203-221.
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Contact:
Russo Partners, LLC
Tony Russo, Ph.D.
CEO
(212)845-4251
tony.russo@russopartnersllc.com
Heidi Chokeir, Ph.D.
Account Executive
(619)814-3512
heidi.chokeir@russopartnersllc.com
