DUOBRII (halobetasol propionate and tazarotene) (IDP-118) lotion demonstrated significant superiority over vehicle as early as two weeks, according to new research in Journal of the American Academy of Dermatology.
DUOBRII (halobetasol propionate and tazarotene) (IDP-118) lotion is an investigational topical treatment for plaque psoriasis. If approved, DUOBRII will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients. 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.
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) 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 during 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," says lead study author Linda Stein Gold, M.D., director, Dermatology Clinical Research, Henry Ford Health System in Detroit, in a news release. "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.