Journal of the American Academy of Dermatology (JAAD) has published positive two Phase III, multicenter, randomized, double-blind clinical trials (Studies 1 and 2) for psoriasis, to assess the safety and efficacy of DUOBRII.- Ortho Dermatologics.

Ortho Dermatologics, a division of Valeant Pharmaceuticals North America, LLC announced that the Journal of the American Academy of Dermatology (JAAD) published for the first time positive results from two Phase III, multicenter, randomized, double-blind clinical trials (Studies 1 and 2) to assess the safety and efficacy of DUOBRII (halobetasol propionate and tazarotene) (IDP-118) lotion in the treatment of plaque psoriasis.

Studies 1 and 2, which enrolled a total of 418 patients, showed DUOBRII was consistently more effective than vehicle in achieving treatment success (defined as those with at least a two-grade improvement from baseline in an Investigator Global Assessment (IGA) score, and 'clear' or 'almost clear' skin), demonstrating statistically significant superiority by week four (in Study 1) and week two (in Study 2). At week eight, 35.8 percent (Study 1) and 45.3 percent (Study 2) had achieved the primary efficacy outcome, compared to 7.0 percent and 12.5 percent on vehicle (both p<0.001). the majority of patients maintained treatment success over the four-week post treatment period.>

DUOBRII was also superior in reducing psoriasis signs and symptoms and body surface area (BSA) affected compared to vehicle. In addition, DUOBRII showed significant reductions in the severity of the clinical signs of psoriasis. The most common treatment-related adverse events were contact dermatitis (6.3 percent), application site pain (2.6 percent) and pruritus (2.2 percent).

The FDA has accepted the New Drug Application for DUOBRII lotion with a Prescription Drug User Fee Act (PDUFA) action date of June 18, 2018.

See- Bulley, et al. "Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of Two Phase III Randomized Controlled Trials." Journal of the American Academy of Dermatology.