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.
For more information visit Ortho-dermatologics.com.