FDA Approves Combination Lotion for Plaque Psoriasis

The US Food and Drug Administration (FDA) has approved a lotion containing halobetasol propionate 0.01% and tazarotene 0.045% (Duobrii) for the treatment of plaque psoriasis. The lotion is indicated for adults and is the first topical treatment for plaque psoriasis to combine halobetasol propionate and tazarotene.

In June 2018, the company received a Complete Response Letter from the FDA citing questions regarding the pharmacokinetic data supporting the application. The application was resubmitted for review in August 2018.

“Since psoriasis is a chronic skin disease, patients require continuous treatment in order to achieve optimal control of their 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,” said Bill Humphries, president, Ortho Dermatologics. “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.”

At the 2019 Annual Meeting of the American Academy of Dermatology in March, MD Magazine® spoke with Lawrence Green, MD, Associate Clinical Professor of Dermatology, George Washington University School of Medicine, Washington, DC, about a post hoc analysis focusing on Hispanic patients in a study of halobetasol propionate and tazarotene lotion.

“Now the halobetasol used in the Duobrii is different than the halobetasol that we all know and love that we've used for years and years,” said Green. “It's a much lower concentration and a much more elegant vehicle where the penetration is enhanced. So, you can get similar amounts of efficacy with the lower strength halobetasol, but more safety.”

Green added that including tazarotene, a retinoid product, in the lotion provides a different mechanism of action for treating a patient’s psoriasis.

Linda Stein Gold, MD, director, Dermatology Clinical Research, Henry Ford Health System, commented that topical retinoids are of limited use as monotherapies due to tolerability issues, which is why the combination of a retinoid and a steroid is key for Duobrii’s efficacy and safety.

“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,” said Linda Stein Gold, MD, director, Dermatology Clinical Research, Henry Ford Health System.

Ortho Dermatologics expects to have the newly-approved halobetasol propionate and tazarotene lotion available by June 2019.