The Food and Drug Administration (FDA) has tentatively approved Bryhali (halobetasol propionate; Bausch Health) Lotion, 0.01%, a potent to superpotent corticosteroid, for the topical treatment of plaque psoriasis in adult patients.

The approval of Bryhali was based on data from 2 randomized, double-blind studies conducted in 430 patients with moderate to severe plaque psoriasis. Results showed that compared with vehicle, a greater number of patients treated with Bryhali achieved treatment success, defined as at least a 2-grade improvement from baseline in Investigator’s Global Assessment (IGA) and an IGA score of “clear” or “almost clear” (Trial 1: 37% vs 8%; Trial 2 and 38% vs 12%). Moreover, in both trials, patients treated with Bryhali were found to have significant treatment success as early as week 2 in Trial 1 and week 4 in Trial 2.

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With regard to safety, Bryhali was well-tolerated in clinical trials with no increase in epidermal atrophy. The most common adverse events associated with therapy included upper respiratory tract infection, application site dermatitis, and hyperglycemia.

“Topical steroids are a cornerstone of psoriasis treatment, but the efficacy of a high-potency steroid often comes with an increased risk of adverse events and a duration of use limited to 2 to 4 weeks,” said Lawrence J. Green, MD, associate clinical professor of Dermatology at George Washington University School of Medicine in Washington, D.C. “In clinical trials Bryhali Lotion has demonstrated good local tolerability for up to 8 weeks of treatment without sacrificing efficacy, making it an important new treatment option for psoriasis patients.”

Bausch Health hopes to make Bryhali Lotion available by November 2018; the final FDA approval is pending the expiration of exclusivity for a related product.

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