Green introduces the combination lotion tested in this clinical trial of patients with moderate-to-sever plaque psoriasis.
A research poster analyzing data from a study of halobetasol propionate 0.01% and tazarotene 0.045% lotion (Duobrii) in Hispanic patients with moderate-to-severe plaque psoriasis found positive efficacy and safety results.
Lawrence Green, MD, Associate Clinical Professor of Dermatology, George Washington University School of Medicine, Washington, DC, and an investigator on the trial, spoke with MD Magazine® about the study at the 2019 Annual Meeting of the American Academy of Dermatology (AAD).
“The focus of the post hoc analysis in the Duobrii poster with Hispanics is to see if the Hispanic population responds similarly or differently than other populations that were treated with Duobrii,” said Green.
Ortho Dermatologics submitted a New Drug Application (NDA) for the lotion, then known as IDP-118, to the US Food and Drug Administration (FDA) that was accepted in November 2017. However, the FDA issued a Complete Response Letter for the Duobrii application due to “questions regarding pharmacokinetic data,” according to a statement at that time by Joseph C. Papa, chairman and CEO of Valeant, a parent company of Ortho Dermatologics. Subsequently, in August 2018, the company resubmitted the Duobrii NDA and the lotion is currently under FDA review.
Green was an author, along with Paul Yamauchi, MD, PhD, and Neal Bhatia, MD, of the poster, “Halobetasol and Tazarotene: Further Defining the Role of a Unique Fixed Combination Topical Lotion in Moderate-to-Severe Plaque Psoriasis in a Hispanic Population.” The poster was shared at the AAD Annual Meeting held March 1-5, 2019, in Washington, DC.
MD Magazine: What treatment were you investigating in the study?
Green: Duobrii is a new product developed by Ortho [Dermatologics] that is a combination product of tazarotene and halobetasol. Tazarotene is a retinoid product used in the treatment of acne and psoriasis and halobetasol is a topical steroid. 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. 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. Then you add tazarotene to it, which is a retinoid that works in a different mechanism of action to treat the psoriasis, combining with the steroid, so you have an enhanced mechanism of action and efficacy.
What was the focus of this post hoc analysis?
The focus of the post hoc analysis in the Duobrii poster with Hispanics is to see if the Hispanic population responds similarly or differently than other populations that were treated with Duobrii.