FDA OKs New Topical Treatment Duobrii for Plaque Psoriasis

Megan Brooks

April 26, 2019

The US Food and Drug Administration (FDA) has approved a lotion containing halobetasol propionate and tazarotene (Duobrii, Bausch Health) for treatment of plaque psoriasis in adults.

Duobrii is the first and only topical lotion that combines both halobetasol propionate and tazarotene in one formulation. 

"Duobrii provides the known benefits of a potent topical corticosteroid and a topical retinoid with synergistic efficacy. Combination therapy is the mainstay of topical treatment for plaque psoriasis, making Duobrii an important new option," Linda Stein Gold, MD, director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, said in a news release from Bausch Health.

"Although effective, topical retinoids have had limited use as monotherapy due to tolerability concerns. Duobrii provides improved local tolerability, allowing patients to benefit from an extended duration of use," she added.

In a phase 2 study, the halobetasol propionate/tazarotene combination lotion was "consistently" more effective than its individual agents and vehicle in achieving treatment success (defined as at least a 2-grade improvement from baseline in an Investigator Global Assessment [IGA] score, and 'clear' or 'almost clear' skin) and reducing signs of psoriasis such as erythema, plaque elevation, and scaling at the target lesion, the company said.

In a post-hoc analysis of the data, in which the vehicle effect was removed, the efficacy of Duobrii was superior to the aggregated results of the individual agents, "supporting the synergy of the two ingredients when combined in one lotion formulation," the company said.

The most common adverse events in clinical trials included redness, itching, swelling, burning, stinging, application site pain, folliculitis, atrophy, peeling, and rash.

Patients with plaque psoriasis require continuous treatment to achieve optimal control of symptoms. "Now, with Duobrii, health care professionals and their patients have a new topical treatment option that can help them achieve those long-term goals. As a result, 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," Bill Humphries, president of Bausch Health's Ortho Dermatologics, said in the release.

Duobrii is expected to be available in June. The lotion is priced at $825 for a supply of a 100-gram tube. Through the company's access program, most eligible, commercially-insured patients will have a co-pay between $25 and $40, the company said.

Roughly 7.5 million people in the US have psoriasis, a chronic, inflammatory skin disorder with a strong genetic basis. Of those, about 80% have plaque psoriasis.

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