Bryhali (halobetasol propionate; Ortho Dermatologics) Lotion 0.01%, a potent to superpotent corticosteroid, is expected to launch later this month for the treatment of plaque psoriasis in adults. The product received tentative approval from the Food and Drug Administration (FDA) in October 2018 and was granted full approval on November 6, 2018.
“We are proud of our efforts to make Bryhali Lotion available as quickly as possible following final approval by the FDA,” said Bill Humphries, president, Ortho Dermatologics. “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.”
The approval was supported by data from 2 prospective, multicenter, randomized, double-blind clinical trials. Results showed treatment with Bryhali once daily for 8 weeks was generally well-tolerated with no increase in epidermal atrophy. Data from Study 1 and Study 2 showed Bryhali led to significant treatment success over vehicle as soon as week 2 (Study 1) and week 4 (Study 2), which continued through 12 weeks.
Upper respiratory tract infection, application site dermatitis, and hyperglycemia were the most common adverse reactions associated with Bryhali Lotion.
Bryhali Lotion will be available in 60g and 100g tubes.
For more information call (800) 321-4576 or visit Bryhali.com.