Ortho Dermatologics, a division of Valeant Pharmaceuticals Intl Inc (NYSE:VRX), announced that the Journal of the American Academy of Dermatology (JAAD) published for the first time positive results from two Phase 3, multicenter, randomized, double-blind clinical trials (Studies 1 and 2) to assess the safety and efficacy of DUOBRIITM1 (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).
“I’ve found that psoriasis patients may benefit from combination therapy with topical agents, many of whom are unsatisfied with current treatment options,” said Linda Stein Gold, M.D., director, Dermatology Clinical Research, Henry Ford Health System. “DUOBRII is a fixed dose combination of halobetasol and tazarotene that has shown synergistic efficacy in the Phase 2 study. Efficacy was again demonstrated in the two Phase 3 studies versus vehicle with minimal side effects in a well-tolerated, patient preferred formulation.”
Halobetasol propionate and tazarotene, when used separately to treat plaque psoriasis, are limited to a four-week or less duration of use and a high rate of adverse events, respectively. Based on existing data from these and other clinical studies, the combination of these ingredients in DUOBRII with a dual mechanism of action, potentially allows for expanded duration of use, with a proven safety profile.
“Topical corticosteroid treatments are a cornerstone of psoriasis treatment, but safety concerns have limited their duration of use for many patients. If approved, DUOBRII will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation,” said Bill Humphries, executive vice president, Dermatology, Ortho Dermatologics. “We are excited by the hope of what DUOBRII may offer patients, and we are committed to working with regulatory authorities to bring this potential new treatment option to market as quickly as possible.”
The U.S. Food and Drug Administration has accepted the New Drug Application for DUOBRII lotion with a Prescription Drug User Fee Act (PDUFA) action date of June 18, 2018.
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