New Product Cleared By FDA Takes Novel Approach To Atopic Dermatitis
Millions affected by chronic skin disease could benefit from new product
CORAL GABLES, Fla., October 19, 2005 -- Stiefel Laboratories, the world's largest independent pharmaceutical company specializing in dermatology, announced that its new product for treating atopic dermatitis - MimyX Cream - has been cleared by the U.S. Food and Drug Administration (FDA) for sales and marketing in the United States.
"We are elated to expand our product offering to include atopic dermatitis, and we are particularly pleased to be able to offer an alternative to dermatologists and pediatricians in treating atopic dermatitis, which is a challenging chronic disease," said Charles Stiefel, President and CEO of Stiefel Laboratories. He added that MimyX Cream is currently available on a prescription-only basis.
MimyX Cream is a topical non-steroidal treatment for the signs and symptoms of atopic dermatitis that can be used in patients of all ages. It takes a totally new approach to treating the condition by restoring the natural structure and components of the stratum corneum, the outermost layer of the skin.
MimyX Cream's unique treatment approach is clinically proven to relieve the signs and symptoms of atopic dermatitis. In addition, essential ingredients found within MimyX Cream mimic natural components of the stratum corneum, thus helping repair and restore skin barrier function. The end result is a safe, effective, hypoallergenic product that restores barrier function while relieving the signs and symptoms of atopic dermatitis without adversely affecting the patient's immune system. The product also contains no emulsifiers, perfumes or dyes that might affect sensitive/allergic patients.
"Having this treatment option that can be used by almost any patient, including children, for longer periods of time than other available medications, gives my fellow physicians and me greater flexibility in tackling atopic dermatitis. I am enthusiastic about adding MimyX to my current atopic dermatitis regimen," said Joseph Jorizzo, M.D., Professor of Dermatology at Wake Forest University School of Medicine.
Atopic dermatitis is often simply referred to as "eczema." It is characterized by extremely itchy skin that leads to persistent scratching. That scratching produces redness, swelling, cracking, "weeping" of clear fluid, and finally, crusting and scaling.
According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), more than 15 million people in the U.S. have symptoms of atopic dermatitis. In addition, children are more commonly affected than adults, with 90 percent of acute dermatitis cases diagnosed by age 5. Roughly 60 percent of infants affected continue to have one or more symptoms of atopic dermatitis into adulthood.
NIAMS researchers project that U.S. health insurance companies spend more than $1 billion per year on atopic dermatitis. Atopic dermatitis has also been found to affect patient quality of life due to its uncomfortable symptoms and how it alters physical appearance.
"Current therapeutic options are not meeting the needs of patients with atopic dermatitis. We believe MimyX Cream offers physicians a safe and effective maintenance therapy option in the arsenal against this condition," said Steve Gallopo, Director, New Product Planning for Stiefel Laboratories.
MimyX Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. MimyX Cream is contraindicated in patients with known hypersensitivity to any of the components of the formulation. In radiation therapy, MimyX Cream may be applied as indicated by the treating Radiation Oncologist. Do not apply 4 hours prior to a radiation session. MimyX Cream does not contain a sunscreen and should not be used prior to extended exposure to the sun. For external use only.
Posted: October 2005
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