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Mechanism Of Action
Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action in plaque psoriasis is unknown.
A vasoconstrictor assay in healthy subjects with ULTRAVATE lotion indicated that the formulation is in the super-high range of potency as compared to other topical corticosteroids; however, similar blanching scores do not necessarily imply therapeutic equivalence.
The potential for hypothalamic-pituitary adrenal (HPA) suppression was evaluated in a study of 20 adult subjects with moderate to severe plaque psoriasis. A mean dose of 3.5 grams ULTRAVATE lotion was applied twice daily for two weeks and produced HPA axis suppression in 5 of 20 (25%) patients. In this study, the criteria for HPA-axis suppression was a serum cortisol level of less than or equal to 18 micrograms per deciliter 30 minutes after stimulation with cosyntropin (adrenocorticotropic hormone). These effects were reversible as recovery of HPA axis function was generally prompt with the discontinuation of treatment [see WARNINGS AND PRECAUTIONS].
The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
In a Phase 2 HPA clinical study [see Pharmacodynamics], pharmacokinetics was evaluated in a subgroup of 12 adult subjects. On Day 8, blood was taken just prior to and at 1, 2, 4, 6, 8, and 12 hours following the last application. Plasma concentration of halobetasol propionate was measureable in all subjects. Based on the geometric mean plasma concentrations at 12 hour post-application across time, steady-state was achieved by Day 8. The mean (±standard deviation) Cmax concentrations for ULTRAVATE lotion on Day 8 was 201.1 ± 157.5 pg/mL, with the corresponding median Tmax value of 3 hours (range 0 – 6 hours); mean area under the halobetasol propionate concentration versus time curve over the dosing interval (AUCτ) was 1632 ± 1147 pg•h/mL.
ULTRAVATE lotion was evaluated for the treatment of moderate to severe plaque psoriasis in two multicenter, randomized, double-blind, vehicle-controlled studies.
These studies were conducted in 443 subjects 18 years of age and older with plaque psoriasis involving between 2% and 12% body surface area. Baseline disease severity was determined using a static, five-level global evaluation scale, on which a subject scored either moderate or severe. Overall, 57% of subjects were male and 86% were Caucasian.
Subjects applied ULTRAVATE lotion or vehicle to all affected areas twice daily for up to 14 consecutive days.
The primary measure of efficacy was Overall Treatment Success, defined as the proportion of subjects who were cleared or almost cleared with at least a two grade improvement from baseline at Week 2 (end of treatment). Table 2 presents these results.
Table 2: Overall Treatment Success in Subjects with
Plaque Psoriasis at Week 2
|Study 1||Study 2|
|Overall Treatment Success*||49 (44.5%)||7 (6.3%)||49 (44.5%)||8 (7.1%)|
|* Subjects whose condition was cleared or almost cleared of all signs of psoriasis and with at least a two grade improvement from baseline.|
Table 3: Individual Signs Treatment Success in
Subjects with Plaque Psoriasis at Week 2
|Treatment Success*||Study 1||Study 2|
|Scaling||61 (55.5%)||12 (10.8%)||65 (59.1%)||11 (9.8%)|
|Erythema||40 (36.4%)||8 (7.2%)||48 (43.6%)||12 (10.7%)|
|Plaque Elevation||50 (45.5%)||9 (8.1%)||48 (43.6%)||9 (8.0%)|
|* Subjects who were cleared or almost cleared of the designated clinical sign with at least a two grade improvement from baseline.|
Last reviewed on RxList: 11/23/2015
This monograph has been modified to include the generic and brand name in many instances.
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