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Bausch Health and its dermatology company, Ortho Dermatologics, recently announced the launch of Bryhali (halobetasol propionate, halopytasol propionate, 0.01%) emulsion in the United States, a topical treatment for plaque psoriasis in adult patients. Bryhali received provisional FDA approval on October 12, 2018 and final approval on November 6, 2018.
local steroids are the most commonly used drugs for psoriasis, but long-term use is limited due to the risk of adverse events such as skin atrophy. Other adverse reactions caused by local steroids include symposomes, capillaries dilation, pigmentation, and contact dermatitis. Local adverse reactions may be irreversible.
Bryhali emulsion is a new powerful corticosteroid hormone drug that contains 0.01% halopytate in an innovative emulsion. The safety of Bryhali lotions has been confirmed in clinical studies, patients with a daily local medication for 8 weeks of continuous treatment, showing good tolerance, and no increase in skin atrophy.
Bryhali lotion was approved based on data from two forward-looking, multi-center, randomized double-blind studies. The study included 430 adults with moderate to severe plaque-type psoriasis aged 18 and over. In 2 studies, 37% and 38% of patients in the Bryhali treatment group achieved treatment success (IGA had at least 2 levels of improvement relative to baseline, IGA score was 0 (removal) or 1 (almost cleared)), and skin atrophy did not increase after 8 weeks of treatment, compared with 8% and 12% of patients in the prophylitic group, respectively. In addition, two studies showed that Bryhali lotions showed significant treatment success during weeks 2 (study 1) and 4 (study 2) of topical use and lasted up to 12 weeks (4 weeks after treatment).
safety, the most common adverse reactions observed in patients with Bryhali's medication for 8 weeks were upper respiratory tract infections (2%), dermatitis (1%) and high blood sugar (1%). The study observed the possibility of reversible hypothyroid-pituitary-adrenal (HPA) axis inhibition, and the possibility of insufficient glucoticoids during or after Bryhali lotion therapy.
Lawrence J. Green, an associate professor of dermatology at the University of Washington School of Medicine, has previously noted that topical steroids are the cornerstone of psoriasis treatment, but the efficacy of highly potency steroids is often associated with an increased risk of adverse events and is limited to 2-4 weeks of use. In clinical studies, Bryhali emulsions have shown good local tolerance for up to 8 weeks without affecting efficacy, and the drug will provide an important new treatment option for the psoriasis patient population. (Bio Valley)