"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
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in the treatment of atopic dermatitis is unknown.
The contribution to efficacy by individual components of the vehicle has not been established.
In an HPA axis suppression trial, three of 75 (4%) pediatric subjects with mild to moderate atopic dermatitis covering at least 25% body surface area, who applied VERDESO Foam twice daily, experienced reversible suppression of the adrenal glands (as indicated by a 30- minute post-stimulation cortisol level ≤ 18 mcg/dL) following 4 weeks of therapy. [See WARNINGS AND PRECAUTIONS and Pediatric Use].
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the product formulation, the integrity of the epidermal barrier, and age. 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 are then excreted by the kidneys. Some corticosteroids and their metabolites are also excreted in the bile.
In a double-blind, randomized trial of 581 subjects aged 3 months to 17 years, with mild to moderate atopic dermatitis, VERDESO Foam was applied twice daily for 4 weeks. Success was defined as the proportion of subjects who had all of the following: an Investigator's Static Global Assessment (ISGA) score of clear or almost clear, a minimum improvement in the 5- point ISGA score of 2 grades from Baseline to Week 4, and a score of absent or minimal for both erythema and induration/papulation at Week 4. The results of this trial are presented in the following table.
Table 2: Results of Clinical Trial in Subjects Aged 3
Months to 17 Years With Mild to Moderate Atopic Dermatitis
|VERDESO Foam||Vehicle Foam|
|Number of Subjects||387||194|
|Subjects Achieving Success||152 (39%)||18 (9%)|
Last reviewed on RxList: 4/18/2013
This monograph has been modified to include the generic and brand name in many instances.
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