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FDA approves new drug application for plaque psoriasis topical lotion
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Bausch Health Companies announced that the FDA has approved its new drug application for Duobrii lotion in the topical treatment of plaque psoriasis in adults.
Duobrii lotion is a topical treatment that contains a combination of 0.01% halobetasol propionate and 0.045% tazarotene.
Bausch Health conducted two phase 3, prospective, multicenter, randomized, double-blind clinical trials in patients aged at least 18 years with moderate to severe plaque psoriasis.
In a phase 2 study, Duobrii achieved treatment success defined as at least a two-grade improvement from baseline in an Investigator Global Assessment (IGA) score and “clear” or “almost clear” skin and also reduced psoriasis signs of erythema, plaque elevation and scaling, according to a company press release.
A post hoc analysis showed the strength of the two ingredients when combined in one lotion formulation over the results of the individual agents alone.
In clinical trials, the most common adverse events were redness, itching, swelling, burning, stinging, application site pain, folliculitis, thinning of the skin, peeling and rash.
The company expects commercial availability in June.