Ortho Dermatologics expects to start distribution of Bryhali (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month.
The company received final approval from the U.S. Food and Drug Administration (FDA) for Bryhali Lotion on Nov. 6, 2018. The Lotion, which is indicated for the topical treatment of plaque psoriasis in adult patients, is a new potent to superpotent corticosteroid in a novel vehicle lotion with safety established for dosing up to eight weeks.
“We are proud of our efforts to make Bryhali Lotion available as quickly as possible following final approval by the FDA,” says Bill Humphries, president, Ortho Dermatologics, in a news release. “In doing so, our customers and their patients now have a new topical treatment option that provides the efficacy of a high-potency steroid with tolerability and longer duration of use. We look forward to engaging physicians in their offices later this month to discuss Bryhali Lotion and its unique attributes to help meet the needs of their patients.”
Bryhali Lotion had initially received a tentative approval from the FDA due to the pending expiration of exclusivity for a related product. The FDA approval of Bryhali Lotion was based on data from two prospective, multicenter, randomized, double-blind clinical trials. In clinical trials, Bryhali Lotion was applied once daily for eight weeks and shown to be generally well-tolerated with no increase in epidermal atrophy. In Study 1 and Study 2, 37 percent and 38 percent of patients, respectively, treated with Bryhali Lotion achieved treatment success (at least a two-grade improvement from baseline in Investigator’s Global Assessment (IGA) and an IGA score equating to “clear” or “almost clear”) at eight weeks, compared to eight percent and 12 percent of patients treated with vehicle. Data from both trials showed that Bryhali Lotion demonstrated significant treatment success over vehicle as early as week two (Study 1) and week four (Study 2), which continued through 12 weeks (four weeks post treatment). The most common adverse reactions, occurring in ≥1 percent of subjects treated with Bryhali Lotion through week eight, were upper respiratory tract infection (2 percent), application site dermatitis (1 percent) and hyperglycemia (1 percent).
“Bryhali Lotion will help address an unmet need for many plaque psoriasis patients,” says Lawrence J. Green, MD, a lead investigator on the Bryhali Lotion Phase 3 studies and associate clinical professor of Dermatology at George Washington University School of Medicine in Washington, D.C. “Topical steroids are the most frequently used treatment for psoriasis, but come with an increased risk of adverse events and a duration of use limited to two to four weeks. With Bryhali Lotion, I’m excited to offer my patients a topical steroid option that can be used for up to eight weeks without sacrificing tolerability, and with proven efficacy.”