Journal of Drugs in Dermatology has published results of two Phase III trials on the safety and efficacy of Bryhali to treat psoriasis- Ortho Dermatologics

Ortho Dermatologics, one of the largest prescription dermatology health care businesses, and its parent company, Bausch Health Companies Inc.have announced that the Journal of Drugs in Dermatology has published results of two Phase III randomized controlled trials (Studies 1 and 2) examining the safety and efficacy of Bryhali (halobetasol propionate) Lotion, 0.01%, an investigational potent to superpotent corticosteroid, in the treatment of moderate-to-severe plaque psoriasis.

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," said Francisco Kerdel, M.D., Florida Academic Dermatology Center. "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.

The U.S. Food and Drug Administration has accepted the New Drug Application for Bryhali Lotion with a Prescription Drug User Fee Act (PDUFA) action date of 5 October 2018.

See-" Safety and Efficacy of a Once-Daily Halobetasol Propionate 0.01% Lotion in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase III Randomized Controlled Trials"- Lawrence J. Green MD,a Francisco A. Kerdel MD,b Fran E. Cook-Bolden MD,c Jerry Bagel MD,d Tina Lin PharmD,e Gina Martin MOT,f Radhakrishnan Pillai PhD,f Robert Israel MD,g Tage Ramakrishna MDg-October 2018 | Volume 17 | Issue 10 | Original Article | 1062 |