Valeant Pharmaceuticals Division Submits NDA to FDA for IDP-118 Topical Lotion for Treatment of Plaque Psoriasis
6 September 2017 - - Ortho Dermatologics, a division of Laval, Quebec-based pharmaceutical and medical device company Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX), has submitted a New Drug Application to the US Food and Drug Administration for IDP-118 (halobetasol propionate and tazarotene) lotion, the company said.
IDP-118 is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene for the treatment of plaque psoriasis.
Both approved to treat plaque psoriasis, halobetasol propionate and tazarotene, when used separately, are limited to a four-week or less duration of use.
Based on existing data from clinical studies, the combination of these ingredients in IDP-118 with a dual mechanism of action, potentially allows for expanded duration of use, with reduced adverse events.
The NDA submitted for IDP-118 includes data from two successful Phase 3 multi-center, randomized, double-blind clinical trials in 418 subjects 18 years of age and older with 3%-12% clinical involvement of the body surface area for plaque psoriasis. 
In both studies, IDP-118 met the primary efficacy endpoint achieving a "clear" to "almost clear" score and at least a 2 grade improvement based on an investigator global assessment at 8 weeks, and clear to almost clear and at least 2 grade improvement during a 4 week follow up visit at week 12.
The NDA also includes a long-term safety study with patients followed for one year. The most common adverse events were contact dermatitis and application site pain.
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.
Ortho Dermatologics, a Valeant Pharmaceuticals International, Inc. company, is dedicated to helping patients in the treatment of a range of therapeutic areas including actinic keratosis, acne, atopic dermatitis, psoriasis, cold sores, athlete's foot, nail fungus and other dermatoses.
The Ortho Dermatologics portfolio includes several leading acne, anti-fungal and anti-infective products.
Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops, manufactures and markets a range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics.