IDP 118 (halobetasol propionate and tazarotene) filed with the FDA for the treatment of plaque psoriasis.- Ortho Dermatologics.

Ortho Dermatologics has submitted a New Drug Application (NDA) to the U.S. FDA for IDP 118 (halobetasol propionate and tazarotene) lotion. 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.

The NDA submitted for IDP-118 includes data from two successful Phase III 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 (IGA) 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 (7.4%) and application site pain (2.6%).

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.