Medication Monitor

Generic Name (Trade Name—Company)
April 30, 2019

Halobetasol propionate and tazarotene

(Duobrii—Bausch Health)
Combination formulation targets plaque psoriasis in adults

Bausch Health announced FDA approval of halobetasol propionate and tazarotene lotion 0.01%/0.045% for topical treatment of plaque psoriasis in adults. It is the first and only topical lotion that combines halobetasol propionate and tazarotene in one formulation.

In a year-long safety study, patients used the lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.

When used separately to treat plaque psoriasis, duration of use of halobetasol propionate is limited by FDA labeling constraints, and use of tazarotene can be limited due to tolerability concerns. 

Safety and efficacy of once-daily use for treatment of plaque psoriasis were assessed in two Phase III prospective, multicenter, randomized, double-blind clinical trials in participants aged 18 years and older with moderate to severe plaque psoriasis.

The majority of responders maintained treatment success over the 4-week posttreatment period. The most common adverse events were redness, itching, swelling, burning, stinging, application-site pain, inflamed hair follicles, thinning of the skin, peeling, and rash.

A third Phase III multicenter, open-label study assessed the drug's long-term safety over a year in participants with plaque psoriasis. Treatment-related adverse events were application-site reactions such as itching, pain, irritation, and inflamed hair follicles.