Live Blog: Product Theater for Valeant Pharmaceuticals – A Scientifically Designed Topical Treatment Option for Toenail Onychomycosis: A Look at the Data including Populations of Interest. Faculty Linda Stein Gold, MD
In this live blog from the Annual Fall SDPA Conference in Orlando, FL, Linda Stein Gold, MD, presented product theater for Valeant Pharmaceuticals called “A Scientifically Designed Topical Treatment Option for Toenail Onychomycosis: A Look at the Data including Populations of Interest.” Here are some of the highlights.
Dr. Stein Gold pointed out that 50% of nail problems are caused by fungus. Other possible diagnoses are non-fungal infection, lichen planus, psorasis, nail trauma, neoplasms, and exogenous substances such as nail polish or medications. T. rubrum causes 90% of fungal infections.
Fungal infection affects the entire nail unit: the nail plate, nail bed, and periungual tissue. It may be associated with significant clinical issues and it is a progressive condition that warrants intervention. Infection may be spread to other body parts and/or other people.
Jublia is an azole antifungal which is indicated for the topical treatment of oncyhomycosis of the toenails due to T. rubrum and Trichophyton mentagrophytes. Through two parallel 52-week, multicenter, randomized, double-blind, vehicle-controlled studies Jublia was proven to treat onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes.
Patients should apply Jublia to affected toenails once daily for 48 weeks using the integrated flow-through brush applicator. When applying Jublia, patients should ensure that the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered. Appropriate application of Jublia is required. One benefit of Jublia is that there is no need for patient counseling for potential liver toxicity and no need for liver function tests. Jublia has a low surface tension, no lacquer buildup, and requires no debridement.
Jublia is for topical use only and is not for oral, ophthalmic, or intravaginal use. Patients should be instructed to contact their health care professional if a reaction suggesting sensitivity or severe irritation occurs.
The most common adverse reactions (incidence >1%) were (vs vehicle): ingrown toenail (2.3% vs 0.7%), application-site dermatitis (2.2% vs 0.2%), application-site vesicles (1.6% vs 0%), and application-site pain (1.1% vs 0.2%).
Jublia is a category C drug and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Jublia should be used with caution in nursing women. The safety and effectiveness in pediatric patients have not been established.
Image: Nick Kidd