Graceway Pharmaceuticals Reports Study in Journal of Pediatrics: Atoplclair is Effective Monotherapy for Mild to Moderate Atopic Dermatitis in Infants and ChildrenBRISTOL, Tenn.--(BUSINESS WIRE)--May 29, 2008 - Graceway Pharmaceuticals, LLC announced today the results of a multicenter, randomized, vehicle-controlled study recently published in the June 2008 issue of the Journal of Pediatrics. The study demonstrated that Atopiclair (MAS063DP) cream is effective and safe as a monotherapy for the treatment of symptoms of mild to moderate atopic dermatitis (eczema or AD) in infants and children.
Dr. Mark Boguniewicz of the National Jewish Medical and Research Center in Denver, Colorado, was the lead investigator for the study. Dr. Boguniewicz commented: "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."
About the Study
This 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. By day 22, investigators rated 77% of patients treated with Atopiclair as either "clear" or "almost clear" of mild to moderate symptoms that were present on day 1. No patients in the vehicle group were rated "clear" or "almost clear" at that time point. 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. The difference between Atopiclair and vehicle was highly significant at every time point (P less than .0001).(1) Itch is especially troubling to infants and young children, who become irritable and uncomfortable.
With Atopiclair, fewer infants and children required topical steroid rescue medication (9%) than in the vehicle group (29%). Topical steroids are a mainstay of therapy whose use may be limited by adverse events. Parents often have safety concerns about using steroids on their children.(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.
Study authors conclude that, "Given the complexity of the skin abnormalities described in AD, the combination of antipruritc, anti-inflammatory, hydrating and barrier-restoring activities of (Atopiclair) resulted in beneficial activity in our population of infants and children with mild to moderate AD."(1)
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.(1) Symptoms and sleep disruptions caused by the disease can negatively impact quality of life for patients and their families.
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. Unlike other topical prescription products, 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 face increased risks 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(R) (imiquimod) Cream, 5%, Maxair(R) Autohaler(R) (pirbuterol acetate inhalation aerosol), Atopiclair(R) Nonsteroidal Cream, and Estrasorb(R) (estradial topical emulsion). Aldara(R), Maxair(R) Autohaler(R), Atopiclair(R) and Estrasorb(R) are trademarks owned by or licensed to Graceway. For more information on Graceway's products, including Important Safety Information, please visit www.gracewaypharma.com.
1. 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. In press.
2. 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.
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.
Graceway Pharmaceuticals, LLC
James Lee, MD, PhD, Chief Medical Officer
Posted: May 2008