Valeant announces phase 3 results for psoriasis treatment IDP-118

[Fred]

Valeant Pharmaceuticals  have 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.

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Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant") today 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.

Source: valeant.com

[Fred]

Update:

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Ortho Dermatologics, a division of Valeant Pharmaceuticals International, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for plaque psoriasis. The PDUFA action date is June 18, 2018.

If approved, IDP-118 will be the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation for the treatment of plaque psoriasis in adult patients, allowing for a potentially expanded duration of use.

[jiml]

Nice to read of something different as a topical being accepted by the FDA let's hope it gets approval
Have they also gone for European approval do you know ?

[Fred]

Nice to read of something different as a topical being accepted by the FDA let's hope it gets approval
Have they also gone for European approval do you know ?

No not as far as I know. They usually go for FDA first.