Valeant announced positive results from a Phase 3 study of IDP-118 (halobetasol propionate and tazarotene lotion) in the treatment of plaque psoriasis.

The 12-week multicenter, double-blind, randomized Phase 3 study included 215 adults with moderate to severe psoriasis. IDP-118 showed statistical significance to vehicle with a treatment success rate of 45.33% and a P<0.001. The primary endpoint was achieved with a “clear” to “almost clear” score based on an Investigator Global Assessment (IGA) at 8 weeks, and at least 2 grade improvements in the IGA at weeks 12, 6, 4 and 2 as secondary endpoints. 

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The company believes, based on existing clinical study data, that the dual mechanism of action of halobetasol propionate, a corticosteroid, and tazarotene, a retinoid, allows for expanded use of these active ingredients with reduced adverse events. 

Valeant expects to have data from a second confirmatory pivotal Phase 3 study in 2017.

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