Successful Phase III trial for IDP 118 (halobetasol propionate and tazarotene) to treat plaque psoriasis.-Valeant Pharma Intl.

Valeant Pharmaceuticals International, Inc. announced positive results from a Phase III, 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 III 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. the phase iii program was preceded by a successful phase ii 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 iii study in 2017.>