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Jublia for Toenail Onychomycosis: Part II

 

Dr. Linda Stein-Gold presented on the use of Jublia (efinaconazole) Topical Solution from Valeant Pharma for Toenail Onychomycosis (TO). Consult Part I of this blog for the background on Toenail Onychomycosis diagnosis provided by Dr. Stein-Gold.

 

 

Dr. Linda Stein-Gold presented on the use of Jublia (efinaconazole) Topical Solution from Valeant Pharma for Toenail Onychomycosis (TO). Consult Part I of this blog for the background on Toenail Onychomycosis diagnosis provided by Dr. Stein-Gold.

Jublia is an new azole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes.  In has shown in vitro penetration and has a low surface tension formulation that allows the drug to drive itself to cover the surface of the nail.

Dosage:

Apply to the affected toenails once daily for 48 weeks using the integrated flow through brush application.

Safety Information:

            Jublia is for topical use only and not for oral, ophthalmic or intravaginal use. 

            The most common adverse reactions occurred in only a small population of patients. 

            Reactions noted were ingrown toenails, application-site dermatitis, vesicles, and pain.

 

How does it get through the nail?

In vitro studies were done to see if the drug would penetrate through the nail plate.  They found that after about 18 days, the drug could get through to the site of action.

 

Formulation of Jublia

Proprietary alcohol-based formulation

Drug is non-lacquer. No need to remove the drug at the end of the week.

Delivered via an integrated flow-through brush applicator.

 

Clincal Study

The efficacy and tolerability of the drug was tested in a 52-week clinical study.  The cohort consisted of 1655 patients with mild to moderate toenail onychomycosis.  They treated their nails for 48 weeks with Jublia or the vehicle and then there was a treatment-free period.  For measurement, the “Primary Endpoint” was defined as complete cure, 0% clinical involvement with a negative KOH and negative fungal culture.  The “Secondary Endpoint” was a complete or almost complete cure: <5% clinical involvement and mycologic cure.

Results

At the end of the 52 weeks, 15-18% of patients had a complete cure.

Between 53-55% of the participants had clear mycologic culture.

 

Efficacy for Geriatric Patients

11.3% of the clinical trails were over age 65 and there were no differences in safety and efficacy in comparison to younger participants.

 

Tolerability

The drug was well-tolerated as only 1-3% of subjects reported adverse events.

 

SUMMARY

Jublia is a new azole specifically formulated to reach the site of the infection.  It is proven to treat onychomycosis of the toenails due to T. rubrum and T. mentagrophytes.  There are no overall differences in safety and effectiveness between patients older than 65 and those younger than 65.  The drug is pregnancy category C.

Dr. Stein-Gold commented that the insert literature is important to consult and educate patients to read.

See also Jublia for Toenail Onychomycosis: Part I

Image: E>mar




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