"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
Mechanism Of Action
The mechanism of action of desonide is unknown.
In an HPA axis suppression study, one of 37 (3%) pediatric subjects, 6 months to 6 years old, with moderate to severe atopic dermatitis covering at least 35% body surface area who applied Desonate experienced suppression of the adrenal glands following 4 weeks of therapy [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]. A follow-up evaluation of the subject's adrenal axis was not performed; it is unknown whether the suppression was reversible.
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including product formulation and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption. Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized primarily in the liver and then are excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.
In two randomized vehicle-controlled clinical studies, subjects 3 months to 18 years of age with mild to moderate atopic dermatitis were treated twice daily for 4 weeks with either Desonate or vehicle. Treatment success was defined as achieving clear or almost clear on the Investigator's Global Severity Score (IGSS) with at least a 2-point change (decrease) from the subject's baseline IGSS when compared to the Week 4 IGSS. The results of the 2 clinical trials are summarized in Table 1:
Table 1: Subjects Achieving Treatment Success
|Clinical Trial 1|
N = 289
N = 92
|128 (44%)||13 (14%)|
|Clinical Trial 2|
N = 136
N = 65
|38 (28%)||4 (6%)|
Last reviewed on RxList: 8/7/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Desonate Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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