Valeant Pharmaceuticals International, Inc. announced positive results from a second confirmatory pivotal 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 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.
"Investing in R&D and developing innovative products that improve people's lives continue to be priorities as we enter 2017," stated Joseph C. Papa, Chairman and Chief Executive Officer. "We are optimistic about the results of this confirmatory Phase 3 study, which demonstrate that the novel formulation in IDP-118, with its dual mechanism of action, can achieve greater efficacy at a much lower concentration while reducing irritation in patients who use a corticosteroid-retinoid combination to treat 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.
On December 8, Valeant announced the results of a prior Phase 3 study of 215 adult subjects with moderate to severe psoriasis. In this study, IDP-118 showed statistical significance (p<0.001) to vehicle with a treatment success rate at 8 weeks of 45.33% to 12.51%. The primary endpoint of the 12-week study (8 weeks of treatment with 4 weeks of follow-up) was achievement of a "clear" to "almost clear" score and at least 2 grade improvement based on an Investigator Global Assessment (IGA) at 8 weeks, and achieving clear to almost clear and at least 2 grade improvement in the IGA at weeks 12, 6, 4 and 2 as secondary endpoints.
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, which demonstrates the IDP-118 formulation is superior to using the individual actives separately.
Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com
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