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.
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.
For more information visit Valeant.com.