Ortho Dermatologics: DUOBRII Shows Superiority Over Vehicle In Two Weeks

(RTTNews) - Ortho Dermatologics, a division of Valeant Pharmaceuticals North America, LLC (VRX, VRX.TO), reported positive results from two Phase 3, multicenter, randomized, double-blind clinical trials (Studies 1 and 2) to assess the safety and efficacy of DUOBRIITM1 lotion in the treatment of plaque psoriasis. The company said the Studies 1 and 2, which enrolled a total of 418 patients, showed DUOBRII was consistently more effective than vehicle in achieving treatment success demonstrating statistically significant superiority by week four (in Study 1) and week two (in Study 2).

The U.S. FDA has accepted the New Drug Application for DUOBRII lotion with a PDUFA action date of June 18, 2018.