Positive first-time results have been published for Duobrii (halobetasol propionate and tazarotene lotion, Ortho Dermatologics) for the treatment of plaque psoriasis. The data appear in the Journal of the American Academy of Dermatology.
Two phase 3, multicenter, randomized, double-blind clinical trials (Studies 1 and 2) assessed the safety and efficacy of Duobrii in a total of 418 patients. The investigational treatment was consistently more effective than vehicle in achieving treatment success (defined as those with at least a two-grade improvement from baseline in an Investigator Global Assessment score, and “clear” or “almost clear” skin), demonstrating statistically significant superiority by week 4 (in Study 1) and week 2 (in Study 2). At week 8, 35.8% (Study 1) and 45.3% (Study 2) of patients had achieved the primary efficacy outcome, compared with 7.0% and 12.5% on the patients using vehicle (both P < 0.001). The majority of patients maintained treatment success over the four-week post-treatment period.
Duobrii also demonstrated superiority in reducing psoriasis signs and symptoms and body surface area affected compared with vehicle. In addition, Duobrii showed significant reductions in the severity of the clinical signs of psoriasis. The most common treatment-related adverse events were contact dermatitis (6.3%), application-site pain (2.6%), and pruritus (2.2%).
Halobetasol propionate and tazarotene, when used separately to treat plaque psoriasis, are limited to a four-week (or less) duration of use and a high rate of adverse events, respectively. Based on existing data from these and other clinical studies, the combination of these ingredients in Duobrii with a dual mechanism of action, potentially allows for expanded duration of use, with a proven safety profile, according to a company press release.
The FDA has accepted the new drug application for Duobrii lotion with a Prescription Drug User Fee Act action date of June 18, 2018.
Source: Valeant Pharmaceuticals International, Inc.; April 9, 2018.