Two Phase 3 randomized controlled trials show that Bryhali (halobetasol propionate) Lotion, 0.01%, an investigational potent to superpotent corticosteroid in the treatment of moderate-to-severe plaque psoriasis, is effective and well-tolerated.
Bryhali Lotion has a Prescription Drug User Fee Act (PDUFA) action date of October 5, 2018.
In the studies, Bryhali Lotion was consistently more effective than vehicle in achieving treatment success, which was defined as at least a two-grade improvement from baseline in an Investigator Global Assessment (IGA) score, and ‘clear’ or ‘almost clear’ skin. By week eight, 36.5 percent (Study 1) and 38.4 percent (Study 2) of Bryhali Lotion patients had achieved treatment success, compared to 8.1 percent and 12 percent of patients receiving vehicle. At four weeks post treatment, no rebound of symptoms was observed in patients using Bryhali Lotion.
Bryhali Lotion was also found to be well-tolerated, with a similar number of patients in the Bryhali Lotion and vehicle groups reporting adverse events (21.5 percent and 23.9 percent, respectively). The most common adverse reactions (≥1%) were upper respiratory tract infection, application site dermatitis and hyperglycemia.
“Though many psoriasis patients may benefit from longer-term treatment options, that has typically not been possible with topical corticosteroids, such as halobetasol, due to concerns about adverse events,” says Francisco Kerdel, M.D., a dermatologist at the Florida Academic Dermatology Center, in a news release. “If approved, Bryhali Lotion can provide physicians and their patients with a new treatment option with a longer duration of use.”
Topical steroids are the most frequently used treatment for psoriasis, but long-term use has been limited due to risks of adverse events, such as epidermal atrophy. Bryhali Lotion was formulated containing 0.01 percent halobetasol propionate in a novel vehicle lotion and was used for up to eight weeks in the clinical trials.
“At Ortho Dermatologics, we continuously strive to better understand the evolving needs of dermatology patients and the providers who treat them each and every day, and we are accelerating our innovation to ensure our portfolio reflects those needs,” says Bill Humphries, president and company group chairman, Ortho Dermatologics. “We believe these new data demonstrate how Bryhali may benefit many psoriasis patients, and we look forward to working with the FDA as the agency completes its review of our New Drug Application.”
About the Phase 3 Studies (Study 1 and 2)
Study 1 and Study 2 were two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies. The studies evaluated the safety and efficacy of Bryhali Lotion, compared to vehicle, among 430 patients 18 years or older with an IGA score of three or four, and affected BSA of three to 12 percent.
Patients were randomized 2:1 to receive Bryhali Lotion or vehicle once-daily for eight weeks, with assessments carried out at two, four, six and eight weeks of treatment, and at a four-week post treatment follow-up visit. The primary efficacy endpoint was the percent of patients who were treatment successes at week eight (defined as those with at least a two-grade improvement from baseline in IGA score, and ‘clear’ or ‘almost clear’ skin). IGA was assessed by the investigator using a five-point scale ranging from zero (clear) to four (severe) at each study visit. Secondary efficacy data were provided at weeks two, four, six and 12. Safety and treatment emergent adverse events were evaluated throughout.