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.
CivicaScript launches droxidopa for symptomatic neurogenic orthostatic hypotension
Padagis' Naloxone HCl Nasal Spray 4 mg obtains extended shelf-life of 36 months
ANI Pharmaceuticals announces US launch of Nitazoxanide Tablets
Newbury Pharmaceuticals secures approval for Macitentan in Denmark
Mallinckrodt and Endo to merge in USD6.7bn deal to create pharmaceutical leader
Genomma Lab Internacional announces quarterly dividend
Aveva Drug Delivery systems introduces generic Fentanyl Transdermal Patch in US
Independent Pharmacy Cooperative signs cooperation agreement with Legacy Pharmacy Group
ILIKOS Consulting partners with Jordan Center for Pharmaceutical Research
Axsome Therapeutics settles patent litigation with Teva over AUVELITY
Breckenridge Pharmaceutical's Everolimus Tablets for Oral Suspension receive US FDA approval
Newbury Pharmaceuticals secures generic approval for pomalidomide in Denmark
Newbury Pharmaceuticals secures generic approval for Bosutinib in Norway
Guangzhou Fermion Technology partners with Simcere Pharmaceutical