New lotion from Ortho Dermatologics expected June 2019.
Ortho Dermatologics, a division of Bausch Health Companies, earned FDA approval of Duobrii (halobetasol propionate and tazarotene), the first and currently only lotion indicated for adults with plaque psoriasis that contains this combination of active ingredients.
At 0.01% halobetasol propionate and 0.045% tazarotene, Duobrii is a prescription topical moisturizing lotion indicated for adults. Effectiveness and safety for pediatric use is unknown at the time of this release.
By combining halobetasol propionate and tazarotene into a single applicant, the former’s limited duration of use and the latter’s variable tolerability in patients is avoided. Used together in the Duobrii’s form, uniform distribution and simultaneous skin surface contact is ensured.1
"DUOBRII offers a unique fixed combination of a topical retinoid and superpotent to potent steroid that work by complimentary mechanisms of action," said Linda Stein Gold, M.D., director, Dermatology Clinical Research, Henry Ford Health System. "It also provides rapid onset of action and has a good safety profile and a cosmetically acceptable vehicle. This new drug will be a welcomed addition to my treatment armamentarium."
Throughout clinical trials, the most adverse events reported included: redness, itching, swelling, burning, stinging, application site pain, folliculitis, atrophy (thinning of the skin), peeling, and rash.
Duobrii is contraindicated for pregnant women, and is not recommended to be used on skin with eczema as it may result in severe irritation.
In a Phase 2 study, Duobrii Lotion was consistently more effective than its individual agents and vehicle in achieving treatment success (at least a two-grade improvement from baseline in an Investigator Global Assessment score and ‘clear’ or ‘almost clear’ skin) and reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion.3
In two Phase 3 prospective, multi-center, randomized, double-blind clinical trials, the lotion was determined to be safe and effective in subjects 18 years and older with moderate to severe plaque psoriasis.1
In a third Phase 3 multicenter, open-label study, subjects continuously applied Duobrii once daily for eight weeks and were re-evaluated every four weeks for one year. Continuous treatment was allowed up to 24 weeks and as needed for up to 52 weeks.2
Duobrii is expected to be available in June, 2019.
1. DUOBRIITM [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC.
2. Lebwohl, M.G. et al. Long-term safety results from a phase 3 open-label study of a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion in moderate-to-severe plaque psoriasis. Journal of American Academy of Dermatology. 2019 Jan;80(1):282-285.
3. Sugarman, J.L. et al. A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Plaque Psoriasis. Journal of Drugs in Dermatology. March 2017: 16(3).