Ortho Dermatologics announced that halobetasol propionate and tazarotene lotion, 0.01%/0.045% (Doubrii, Ortho Dermatologics) is now commercially available to healthcare providers, according to a press release issued June 25.
“The DUOBRII formulation brings together two well-known ingredients in a unique lotion vehicle with low concentrations of halobetasol propionate and tazarotene, into a single, first-of-its-kind topical treatment,” says Bill Humphries, president, Ortho Dermatologics.
Approved by the U.S. Food and Drug Administration in April 2019, the prescription topical’s combination of ingredients allows for uniform distribution and simultaneous skin surface contact, according to the company.
In a phase 2 multicenter, double-blind, randomized, vehicle controlled study, the lotion achieved more effective treatment success (at least a two-grade improvement from baseline in an Investigator Global Achievement score and “clear” or almost “clear skin”) when compared with its individual agents and vehicle. Investigators also reported that study participants showed a reduction in psoriasis signs, such as erythema, plaque elevation and scaling at target lesions.
Researchers of two phase 3 prospective, multi-center, randomized, double-blind clinical trials found that the topical was safe and effective in participants 18 years or older with moderate-to-severe psoriasis. A third phase 3 multicenter, open-label study evaluating the long-term safety over the course of a year found the most common treatment-related adverse evets were application site reactions such as itching, pain, irritation and folliculitis.
The lotion can be dosed to clearance as long as patients do not experience any local skin reactions; however, treatment should be stopped once clearance is achieved, the company states.
The topical is priced at $825 for a supply of a 100-gram tube.