Second successful Phase III trial ofIDP 118 (halobetasol propionate and tazarotene) lotion to treat plaque psoriasis.- Valeant Pharma International.

Valeant Pharmaceuticals International, Inc.announced positive results from a second confirmatory pivotal 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 203 adult subjects with moderate to severe psoriasis, IDP 118 showed statistical significance (p < 0.001) to vehicle with a treatment success rate at 8 weeks of 35.76% to 6.98%. The primary endpoint of the 12-week study (8 weeks of treatment followed by 4 weeks of follow-up) was achievement of a "clear" to "almost clear" score and at least a 2 grade improvement based on an Investigator Global Assessment (IGA) at 8 weeks, and clear to almost clear and at least 2 grade improvement in the IGA at weeks 12, 6, 4 and 2 as secondary endpoints.

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 the 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.

Comment: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, which demonstrates the IDP 118 formulation is superior to using the individual actives separately.