FDA Approves Bryhali Lotion for Plaque Psoriasis for 8 Weeks of Use

The FDA has extended the approved use of Bryhali (halobetasol propionate) Lotion .01% for up to 8 weeks in adults with plaque psoriasis.

Lawrence J. Green, MD

The US Food and Drug Administration (FDA) has approved Bryhali (halobetasol propionate) Lotion .01% for up to 8 weeks of use in adults with plaque psoriasis.

"Bryhali Lotion will help address an unmet need for many plaque psoriasis patients," said 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, DC. "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 2 to 4 weeks. With Bryhali Lotion, I'm excited to offer my patients a topical steroid option that can be used for up to 8 weeks without sacrificing tolerability, and with proven efficacy."

Data from 2 phase 3 multicenter, double-blind trials supported the FDA’s decision. The trials included patients with plaque psoriasis covering a body surface area of 3-12%. In trial 1, 217 participants were randomized to either halobetasol propionate lotion .01% (n = 143) or unmedicated vehicle lotion (n = 74). In trial 2 (n = 213), those numbers were 142 and 71, respectively.

After 8 weeks of daily treatment application to areas affected by plaque psoriasis, there was a 4-week period without treatment and a follow-up visit to evaluate efficacy and safety. Disease severity was measured at weeks 2, 4, 6, 8, and 12 by a 5-grade Investigator’s Global Assessment (IGA).

Treatment success was defined as ≥2-grade improvement in IGA from baseline and an IGA score equivalent to “clear” or “almost clear” at week 8. In trial 1, 37% of participants in the Bryhali Lotion group were successfully treated, compared to 8% of the vehicle group; in trial 2, those numbers were 38% and 12%, respectively.

Bryhali lotion demonstrated statistically significant treatment success over vehicle as early as week 2 in trial 1 and week 4 in trial 2, which continued through week 12.

"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.”

According to the Bryhali Lotion Prescribing Information, the most common adverse reaction (≥1%) were upper respiratory tract infection (2%), application site dermatitis (1%), and hyperglycemia (1%). Treatment is recommended for only as long as necessary to achieve control, and no longer than 8 weeks.

The company expects to start distribution of Bryhali Lotion later this month.