Bausch Health Companies Inc and its dermatology business, Ortho Dermatologics, announce that the US Food and Drug Administration (FDA) has approved the New Drug Application for DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults.

“With [the] approval of DUOBRII, patients suffering from plaque psoriasis now have an innovative topical treatment option that uniquely combines two well-known ingredients, halobetasol propionate and tazarotene, with established safety profiles, into a single lotion featuring dual mechanisms of action,” says Bill Humphries, president, Ortho Dermatologics, in a media release.

“Since psoriasis is a chronic skin disease,¬†patients require continuous treatment in order to achieve optimal control of their symptoms. Now, with DUOBRII, health care professionals and their patients have a new topical treatment option that can help them achieve those long-term goals.”

When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited by FDA labeling constraints and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in an advanced, patented once-daily moisturizing lotion, the DUOBRII formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface, according to the release.

“DUOBRII provides the known benefits of a potent topical corticosteroid and a topical retinoid with synergistic efficacy. Combination therapy is the mainstay of topical treatment for plaque psoriasis, making DUOBRII an important new option,” stataes Linda Stein Gold, MD, director, Dermatology Clinical Research, Henry Ford Health System, in the release.

“Although effective, topical retinoids have had limited use as monotherapy due to tolerability concerns.¬†DUOBRII provides improved local tolerability, allowing patients to benefit from an extended duration of use.”

[Source(s): Bausch Health Companies Inc, PR Newswire]