New Drug Extends Remission of Atpic Dermatitis

Stiefel Laboratories, the world's largest independent pharmaceutical company specializing in dermatology, announced that a recent study shows MimyX(TM) Cream extends the remission period of atopic dermatitis (AD) by 48 percent when used in conjunction with an emollient compared to emollient alone. MimyX(TM) Cream, Stiefel's new product for managing the signs and symptoms of atopic dermatitis, is a steroid-free, topical Rx therapy for the management of the disease, commonly referred to as eczema.
Most eczema patients will experience periods of "flares" where they have noticeable signs and symptoms of AD alternating with periods of remission where no symptoms are present. According to the 12-week MimyX study involving 74 individuals, MimyX(TM) Cream extends AD remission by 48 percent and may actually reduce the total number of flares a person experiences. The study also shows a 25 percent greater incidence of AD flare-ups on the side of the body where only an emollient was used, as opposed to the side of the participant's body where MimyX(TM) Cream was used in conjunction with an emollient.
"The data collected in this study is very beneficial for understanding and managing atopic dermatitis," said Dr. Joseph Fowler, University of Louisville. "By extending the remission of eczema, we can reduce the total number of flares a patient may experience, and quite possibly lessen the need for adjunctive therapy such as steroids, immunomodulators and systemic antihistamines."
MimyX(TM) Cream is unique from other eczema treatments in that it can be used throughout the AD continuum. MimyX(TM) Cream can be used along with a short-term anti-inflammatory agent during flares and it can also be used without the anti-inflammatory for daily management during remission. (1)
According to Jim Hartman, Vice President, U.S. Marketing, Stiefel, this is a significant finding.
"This study justifies MimyX(TM) as a potential foundation therapy for atopic dermatitis," Hartman said. "Not only is it useful for the management of the signs and symptoms of AD, it has also been shown clinically to extend remission periods of the disease."
Time To Flare Study Background
The objective of the MimyX(TM) Cream Time to Flare (TTF) study was to determine the efficacy of twice daily application of MimyX(TM) Cream added to twice daily emollient maintenance therapy in reducing the risk of relapse of chronic AD. Specifically, the addition of MimyX(TM) Cream to emollient therapy was compared to emollient therapy alone with regard to time until flare.
This was a six-center, investigator-blinded, randomized bilateral study in which subjects with AD were assigned to one of two groups. Group 1 applied MimyX(TM) Cream twice daily to all affected areas on the right side of the body. Group 2 applied MimyX(TM) Cream twice daily on all affected areas on the left side of the body. After applying MimyX(TM) Cream, subjects in both groups applied a non-medicated emollient (Eucerin® Cream) twice daily to the same areas on both sides of the body and any other areas of dry skin. Therapy occurred over a 12-week period with examinations of the subjects initially (week 0, visit 1) and at weeks 2, 4, 6, 8, 10 and 12 (visits 2-7). Rescue medication (Triamcinolone Cream 0.1%) was provided in the event of flare.
Approximately 4 percent of patients experienced adverse events (possibly or probably) related to the use of MimyX Cream like burning (n=1), uticaria (n=1) and headache (n=1) during the study.