Valeant Pharmaceuticals International announced positive results from a Phase 3, multicenter double-blind, randomized, vehicle-controlled clinical study to assess the safety and efficacy of IDP-118 (halobetasol propionate and tazarotene) lotion in the treatment of plaque psoriasis.
Within the Phase 3 study of 215 adult subjects 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 of the 12-week study was achievement of a "clear" to "almost clear" score based on an Investigator Global Assessment (IGA) at 8 weeks, and at least 2 grade improvement in the IGA at weeks 12, 6, 4 and 2 as secondary endpoints.
"We are pleased to share the positive results from the Phase 3 study of this important new formulation," stated Joseph C. Papa, Chairman and Chief Executive Officer. "Psoriasis is often difficult to treat, and dealing with this life-long condition can significantly impact a patient's quality of life. Valeant remains committed to continued research into innovative new treatments to improve the lives of those who suffer from psoriasis."
While halobetasol propionate and tazarotene are both approved and used to treat plaque psoriasis, each has certain attributes that can influence the treatment duration owing to potential adverse events. Based on existing data from our clinical studies, the combination of these ingredients in IDP-118 with a dual mechanism of action potentially allows for expanded use of these active ingredients with reduced adverse events.
The Phase 3 program was preceded by a successful Phase 2 study where the combination product IDP-118, with a treatment success rate of 52.5%, was superior to each of the actives halobetasol propionate and tazarotene as well as the vehicle. Valeant expects to have data from a second confirmatory pivotal Phase 3 study in 2017.