If approved, this will be the first and only topical lotion that contains a unique combination formula.
Ortho Dermatologics, has announced that the US Food and Drug Administration (FDA) accepted the New Drug Applications (NDA) for halobetasol propionate and tazarotene (IDP-118) lotion, a topical treatment for plaque psoriasis in adults.
If approved IDP-118 will be the first and only topical lotion, containing a unique combination of halobetasol propionate and tazarotene in 1 formula for the treatment of plaque psoriasis in adult patients, allowing a potentially expanded duration of use.
“IDP-118 will provide us with a fixed combination of drugs that work by complimentary mechanisms of action in a well-tolerated once daily lotion.” Linda Stein Gold, MD, Henry Ford Health System, told MD Magazine.
Approved to treat plaque psoriasis, halobetasol propionate and tazarotene, when used separately, are limited to a 4 week or less duration of use. Based on existing data from clinical studies, the combination of the ingredients with a dual mechanism of action allows for a potential expanded duration of use, with reduced adverse effects.
The NDA application is based off data from 2 successful phase 3 multi center, double blind, randomized study in 418 subjects, 18 years and older, with a clinical involvement of the body surface area for plaque psoriasis. The NDA also includes a long-term safety study on patients for 1 year.
In the phase 3 studies, IDP-118 showed a statistical significance to vehicle with a treatment success rate of 45.33%. The primary endpoint was achieved with a clear to almost clear score based on an Investigator Global Assessment (IGA) at week 8, and at least 2 grade improvements in the IGA at weeks 2, 4, 6 and 12 as secondary endpoints.
The primary outcome measure included a percent of subjects who experience a local skin reaction graded at a level of 3 on the IGA scale, at any point in the study.
The most common adverse effects experienced were contact dermatitis, 7.4% and application site pain 2.6%.
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 halobetasol propionate and tazarotene and the vehicle, demonstrating the formulation is superior to using the individual actives separately.
The Prescription Drug User Fee Act (PDUFA) date is set for June 18, 2018.
A press release has been made available.