Jublia (efinaconazole) 10% topical gel

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved June 2014

Specific Treatments:

onychomycosis of the toenails

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General Information

Jublia (efinaconazole) is an azole antifungal.

Jublia is specifically indicated for the topical treatment of onychomycosis of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Jublia is supplied as a gel for topical administration. Apply Jublia to affected toenails once daily for 48 weeks, using the integrated flow-through brush applicator. When applying Jublia, ensure the toenail, the toenail folds, toenail bed, hyponychium, and the undersurface of the toenail plate, are completely covered.

Clinical Results

FDA Approval

The FDA approval of Jublia was based on two 52-week prospective, multi-center, randomized, double-blind clinical trials in patients 18 years and older (18 to 70 years of age) with 20% to 50% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement. The trials compared 48-weeks of treatment with Jublia to the vehicle solution. The Complete Cure rate was assessed at Week 52 (4-weeks after completion of therapy). Complete cure was defined as 0% involvement of the target toenail (no clinical evidence of onychomycosis of the target toenail) in addition to Mycologic Cure, defined as both negative fungal culture and negative KOH. Trial One: Percentage of subjects with Complete Cure: Jublia 17.8% versus Vehicle 3.3%; Percentage of subjects with Mycologic Cure: Jublia 55.2% versus Vehicle 16.8%. Trial Two: Percentage of subjects with Complete Cure: Jublia 15.2% versus Vehicle 5.5%; Percentage of subjects with Mycologic Cure: Jublia 53.4% versus Vehicle 16.9%. 

Side Effects

Adverse effects associated with the use of Jublia may include, but are not limited to, the following:

  • ingrown toenails
  • application site dermatitis
  • application site vesicles
  • application site pain

Mechanism of Action

Jublia (efinaconazole) is an azole antifungal. Azole antifungals inhibit the synthesis of ergosterol (the main fungal sterol).

Additional Information

For additional information regarding Jublia or onychomycosis of the toenails, please visit http://www.Valeant.com