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Desonate Gel 0.05% is released for treatment of Atopic Dermatitis

Posted on February 14th, 2007 in FDA News by admin | 942 Views | Print This Post/Page

CARLSBAD, Calif., /PRNewswire - SkinMedica, Inc., a specialty pharmaceutical company focused on developing, acquiring, and commercializing products that treat dermatologic conditions and diseases and improve the appearance of skin, today announced the commercial availability of Desonate(TM) (desonide) Gel 0.05% for treatment of mild-to-moderate atopic dermatitis. Collaboratively developed by SkinMedica and Dow Pharmaceutical Sciences, Inc., Desonate is a low-potency topical steroid formulated in Dow’s proprietary water-based Hydrogel vehicle.

Desonate, which has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of atopic dermatitis in patients aged 3 months and older for up to four consecutive weeks, is an appropriate therapy for both pediatric and adult patients. Formulated with desonide, the leading low-potency corticosteroid used in dermatology, Desonate is the first and only treatment for atopic dermatitis formulated with patented Hydrogel Technology. The versatile formulation can be used on hair-bearing and non-hair-bearing skin, and is free of alcohol, fragrance, or surfactants that can be irritating or drying to the skin.

Desonate will be jointly promoted by SkinMedica and Galderma Laboratories, L.P. SkinMedica will promote Desonate to the dermatology market, while Galderma will promote Desonate to pediatricians via its highly specialized pediatric sales force.

The efficacy and safety of Desonate was demonstrated in controlled clinical trials, which assessed the product’s ability to clear atopic dermatitis symptoms in patients with mild-to-moderate disease. At the 65th Annual Meeting of the American Academy of Dermatology (AAD) in Washington, D.C. (February 2-6, 2007), clinical data supporting Desonate benefits were unveiled.

Atopic dermatitis affects more than 15 million patients, resulting in rash, redness, swelling, crusting, and scaling of the skin. The disease affects nearly 20% of infants and young children, some of which continue to experience symptoms as adults. The exact cause is unknown; however, genetics and environmental factors are considered key factors. Topical corticosteroids are the “gold standard” of treatment for atopic dermatitis, with more than $1 billion in prescriptions written annually by U.S. physicians for inflammatory dermatoses.

 
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