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FDA approves corticosteroid-retinoid lotion for plaque psoriasis


 

The Food and Drug Administration has approved a topical combination of corticosteroid halobetasol propionate (0.01%) and the topical retinoid, tazarotene (0.045%), in a lotion formulation, for the treatment of plaque psoriasis in adults, the manufacturer announced on April 25.

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A press release from the manufacturer, Ortho Dermatologics, summarized the results of two phase 3 studies that compared treatment with the combination product, in 418 adults with moderate to severe plaque psoriasis. At week 8, the proportion of patients who had achieved treatment success – defined as at least a two-grade improvement in Investigator Global Assessment score and a score of “clear” or “almost clear” – was 36% and 45% in the treatment groups, compared with 7% and 13% of those on vehicle, respectively (P less than .001 for both).

The release also refers to a phase 2 study of 212 patients, which found that the combination treatment was more effective in treating plaque psoriasis than was either component separately (J Drugs Dermatol. 2017 Mar 1;16[1]:197-204). By week 8, 52.5% of patients treated with the combination lotion had shown treatment success – compared with 33.3% of those treated with halobetasol, 18.6% of those treated with tazarotene, and 9.7% of those treated with vehicle (P = .033).

Common treatment-related adverse events included treatment site reactions, such as irritation, pain, itching, and folliculitis. Treatment may cause birth defects if used during pregnancy, so a negative pregnancy test should be obtained before treatment begins and effective birth control should be used during treatment.

It will be marketed under the trade name Duobrii and is priced at $825 for a 100-gram tube, according to the press release.

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