Ortho Dermatologics announces publication of Phase 3 data on Bryhali Lotion
Ortho Dermatologics and its parent company, Bausch Health Companies, announced that the Journal of Drugs in Dermatology has published results of two Phase 3 randomized controlled trials examining the safety and efficacy of BRYHALITM 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 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 score, and 'clear' or 'almost clear' skin. By week eight, 36.5% and 38.4% of BRYHALI Lotion patients had achieved treatment success, compared to 8.1% and 12% 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% and 23.9%, respectively). The most common adverse reactions were upper respiratory tract infection, application site dermatitis and hyperglycemia. The U.S. Food and Drug Administration has accepted the New Drug Application for BRYHALI Lotion with a Prescription Drug User Fee Act action date of October 5, 2018.