"(Reuters) - Valeant Pharmaceuticals International Inc's experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said"...
Mechanism of Action
Like other topical corticosteroids, mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Studies performed with ELOCON Cream indicate that it is in the medium range of potency as compared with other topical corticosteroids.
In a study evaluating the effects of mometasone furoate cream on the HPA axis, 15 grams were applied twice daily for 7 days to six adult subjects with psoriasis or atopic dermatitis. The cream was applied without occlusion to at least 30% of the body surface. The results showed that the drug caused a slight lowering of adrenal corticosteroid secretion [see WARNINGS AND PRECAUTIONS].
Ninety-seven pediatric subjects ages 6 to 23 months with atopic dermatitis were enrolled in an open-label HPA axis safety study. ELOCON Cream was applied once daily for approximately 3 weeks over a mean body surface area of 41% (range 15%-94%). In approximately 16% of subjects who showed normal adrenal function by Cortrosyn test before starting treatment, adrenal suppression was observed at the end of treatment with ELOCON Cream. The criteria for suppression were: basal cortisol level of ≤ 5 mcg/dL, 30-minute post-stimulation level of ≤ 18 mcg/dL, or an increase of < 7 mcg/dL. Follow-up testing 2 to 4 weeks after stopping treatment, available for 5 of the subjects, demonstrated suppressed HPA axis function in one subject, using these same criteria [see Use in Specific Populations].
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Studies in humans indicate that approximately 0.4% of the applied dose of ELOCON Cream enters the circulation after 8 hours of contact on normal skin without occlusion. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
The safety and efficacy of the ELOCON Cream for the treatment of corticosteroid-responsive dermatoses were evaluated in two randomized, double-blind, vehicle-controlled clinical trials, one in psoriasis and one in atopic dermatitis. A total 366 subjects (12-81 years of age), of whom 177 received ELOCON Cream and 181 subjects received vehicle cream, were evaluated in these trials. ELOCON Cream or the vehicle cream were applied once daily for 21 days.
The two trials showed ELOCON Cream is effective in the treatment of psoriasis and atopic dermatitis.
Last reviewed on RxList: 2/13/2017
This monograph has been modified to include the generic and brand name in many instances.
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