JUBLIA—Phase 4 efficacy in pediatric patients (N=60) (additional end point)

40% of pediatric patients achieved complete cure with JUBLIA1

  Complete cure rate at 52 weeks after 48 weeks of active treatment

  Mycological Cure at 52 Weeks   Complete/Almost Complete Cure at 52 Weeks

The safety and efficacy of JUBLIA were assessed in a Phase 4 multicenter, open-label, single-arm study of pediatric patients (6-16 years) with at least mild toenail distal lateral subungual onychomycosis (defined as ≥20% clinical involvement of the target toenail, without dermatophytomas or matrix [lunula] involvement) on at least one great toenail (N=60). The pharmacokinetics of JUBLIA were assessed in a subset of patients aged 12-16 years with ≥50% clinical involvement of both great toenails plus onychomycosis in ≥4 additional toenails (n=15).1

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The safety and efficacy of JUBLIA were assessed in a Phase 4 multicenter, open-label, single-arm study of pediatric patients (6-16 years) with at least mild toenail distal lateral subungual onychomycosis (defined as ≥20% clinical involvement of the target toenail, without dermatophytomas or matrix [lunula] involvement) on at least one great toenail (N=60). The pharmacokinetics of JUBLIA were assessed in a subset of patients aged 12-16 years with ≥50% clinical involvement of both great toenails plus onychomycosis in ≥4 additional toenails (n=15).1

*This offer is only valid for most eligible 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 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.

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 below 6 years of age have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Click here for full Prescribing Information.

Reference: 1. Data on file. Bridgewater, NJ: Bausch Health US, LLC.

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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 below 6 years of age have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact Ortho Dermatologics at 1-800-321-4576 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

Click here for full Prescribing Information.

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