JUBLIA—Mycological cure (secondary end point)

  • In Study 1, JUBLIA achieved 55.2% (362/656) mycological cure vs 16.8% (36/214) with vehicle1
  • In Study 2, JUBLIA achieved 53.4% (310/580) mycological cure vs 16.9% (34/201) with vehicle1
  • Mycological cure defined as negative fungal culture and negative KOH examination of the target toenail1

Mycological cure was a component of complete cure.1

In 2 identical, multicenter, randomized, parallel-group, double-blind, vehicle-controlled studies, patients with mild to moderate toenail distal lateral subungual onychomycosis (defined as 20%-50% clinical involvement of the target toenail, without dermatophytomas or matrix [lunula] involvement) were randomized to receive efinaconazole 10% solution or vehicle.2

Debridement was not performed in these studies.2

  Mycological onychomycosis cure at 52 weeks

Indication

JUBLIA (efinaconazole) topical solution, 10% is indicated for the topical treatment of onychomycosis (tinea unguium) of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Important Safety Information

  • 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 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and should be used with caution in nursing women. The safety and effectiveness in pediatric patients have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see JUBLIA Prescribing Information.

*This offer is only valid for patients with commercial insurance. Eligible uninsured patients will pay more. This offer is not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any federal, state, or other governmental programs, including, but not limited to, Medicare (including Medicare Advantage and Part A, B, and D plans), Medicaid, TRICARE, Veterans Administration or Department of Defense health coverage, CHAMPUS, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs. This offer is good only in the U.S. at retail pharmacies owned and operated by Walgreen Co. (or its affiliates) or other participating independent retail pharmacies. This offer is not valid in Massachusetts or Minnesota or where otherwise prohibited, taxed or otherwise restricted. Click here for other terms and conditions that apply.

References: 1. JUBLIA [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2016. 2. Elewski BE, Rich P, Pollak R, et al. Efinaconazole 10% solution in the treatment of toenail onychomycosis: two phase III multicenter, randomized, double-blind studies. J Am Acad Dermatol. 2013;68:600-608. 3. Data on file. Valeant Pharmaceuticals North America LLC.

INDICATION

JUBLIA (efinaconazole) topical solution, 10% is indicated for the topical treatment of onychomycosis (tinea unguium) of the toenail(s) due to Trichophyton rubrum and Trichophyton mentagrophytes.

Please see JUBLIA Prescribing Information.

IMPORTANT SAFETY INFORMATION

  • 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 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and should be used with caution in nursing women. The safety and effectiveness in pediatric patients have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.