Ortho Dermatologics has announced that the New Drug Application (NDA) for their investigational topical treatment for plaque psoriasis, IDP-118 (halobetasol propionate and tazarotene) lotion, has been accepted by the Food and Drug Administration (FDA).
The Company had announced results from a 12-week multicenter, double-blind, randomized study of IDP-118 last December. The trial included a total of 215 adults with moderate to severe psoriasis. IDP-118 showed statistical significance to vehicle with a treatment success rate of 45.33% (P <0.001).
The primary endpoint was achieved with a “clear” to “almost clear” score based on an Investigator Global Assessment (IGA) at 8 weeks, and at least 2 grade improvements in the IGA at weeks 12, 6, 4 and 2 as secondary endpoints.
The most common adverse events recorded were contact dermatitis (7.4%) and application site pain (2.6%). If approved, IDP-118 will be the first topical lotion to contain a combination of halobetasol propionate and tazarotene in one formulation for plaque psoriasis.
The Prescription Drug User Fee Act (PDUFA) action date is June 18, 2018.
Ortho Dermatologics announces US FDA filing acceptance for IDP-118, novel plaque psoriasis treatment [press release]. Quebec; Valeant: November 2, 2017. Accessed November 3, 2017.
This article originally appeared on MPR