Ortho Dermatologics’ Duobrii (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, is now available.
Approved by the U.S. Food and Drug Administration on April 25, 2019, Duobrii is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation.
Duobrii Lotion is priced at $825 for a supply of a 100-gram tube, which is more than 50 percent lower than other branded topical combination products, the Company points out, Additionally, through the company’s access program, most eligible, commercially insured patients will have a co-pay as little as $25.
“The launch of Duobrii marks the fifth innovative therapy that Ortho Dermatologics has brought forward within the last 30 months,” says Bill Humphries, president, Ortho Dermatologics, in a news release.“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. We are proud to provide plaque psoriasis patients this important new option, which offers strong efficacy and an extended duration of use in an advanced once daily lotion that can be dosed to clearance.”
When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited by FDA labeling constraints to two to four weeks duration and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in a patented once-daily moisturizing lotion, however, the Duobrii formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface.
In a year-long safety study, patients used Duobrii for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.2Unlike other topical products that either contain steroids or are steroids on their own, Duobrii is not restricted to eight weeks or less of use. The approved labeling for Duobrii does not include a duration limitation; it can be dosed to clearance as long as local skin reactions do not occur, and treatment should be discontinued once clearance is achieved.
“Combination therapy is an important tool in the treatment of plaque psoriasis and, with the launch of Duobrii, I am excited to offer patients a new option that provides the known benefits of a potent topical corticosteroid and a topical retinoid, with synergistic efficacy,” says Lawrence J. Green, M.D., associate clinical professor of Dermatology, George Washington University School of Medicine, Washington, D.C. “Due to its tolerability profile, I believe many psoriasis patients will be able to benefit from the longer duration of use possible with Duobrii.”
Dr. Green shared more on his experience with Duobrii in the June issue of Practical Dermatology®.