The Food and Drug Administration (FDA) has approved Duobrii (halobetasol propionate 0.01% and tazarotene 0.045%; Ortho Dermatologics) for the topical treatment of plaque psoriasis in adult patients.

Duobrii combines halobetasol propionate, a corticosteroid, with tazarotene, a retinoid prodrug, into a lotion formulation. The approval was based on data from 2 double-blind clinical trials evaluating the safety and efficacy of the topical combination therapy in patients with moderate to severe plaque psoriasis (N=418).

The primary efficacy endpoint of the study was the proportion of patients with “treatment success” at Week 8, defined as at least a 2-grade improvement from baseline in the Investigator’s Global Assessment (IGA) score and an IGA score equating to “clear” or “almost clear”.

Results showed that compared with vehicle, a greater percentage of patients treated with Duobrii achieved IGA treatment success at Week 8 compared with those treated with vehicle (Trial 1: Duobrii 36% vs vehicle 7%; Trial 2: Duobrii 45% vs vehicle 13%).

In addition, a phase 3, open-label study evaluated the long term safety of Duobrii over 1 year; continuous treatment was allowed for 24 weeks and as needed for up to 52 weeks. The study found that adverse events were infrequent and were consistent with those seen with topical corticosteroids and retinoids.

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“Since psoriasis is a chronic skin disease, patients require continuous treatment in order to achieve optimal control of their symptoms,” said Bill Humphries, president, Ortho Dermatologics. “We believe that Duobrii has the potential to delay some patients from switching to more expensive biologic treatments, which could potentially result in health care savings.

Each gram of Duobrii Lotion contains 0.1mg (0.01%) halobetasol propionate and 0.45mg (0.045%) tazarotene. The product is supplied in 100g tubes with a list price of $825. Duobrii is expected to be available in June 2019

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