FDA approves first ever combination lotion for Plaque Psoriasis

The U.S Food and Drug Administration (FDA) has approved a topical lotion for the treatment of plaque psoriasis in adults, the most common form of psoriasis. The lotion is the first topical treatment having a combination of halobetasol propionate and tazarotene. The drug will be marketed by the brand name "DUOBRII^TM" for the treatment plaque psoriasis. The news was announced by Bausch Health on 25 of April 2019.

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. DUOBRII is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation. In a year-long safety study, patients used DUOBRII Lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use. DUOBRII is expected to be available in June 2019.

Plaque psoriasis is the most common type of psoriasis, a chronic, non-contagious skin disease that alters the life cycle of skin cells, causing them to build up rapidly on the surface of the skin.

"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," said Linda Stein Gold, M.D., director, Dermatology Clinical Research, Henry Ford Health System. "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."

A Phase 2 study demonstrated DUOBRII Lotion was consistently more effective than its individual agents and vehicle in achieving 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 reducing psoriasis signs of erythema, plaque elevation, and scaling at the target lesion.

The safety and efficacy of the once-daily use of DUOBRII for the treatment of plaque psoriasis were assessed in two Phase 3 prospective, multi-center, randomized, double-blind clinical trials in subjects 18 years and older with moderate to severe plaque psoriasis.

"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. As a result, we believe that DUOBRII has the potential to delay some patients from switching to more expensive biologic treatments, which could potentially result in health care savings."

DUOBRII Lotion has shown its effectivity in adults. However, its effectivity in children is still not known.