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
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.
References: 1. JUBLIA [prescribing information]. Bridgewater, NJ: Bausch Health US, LLC. 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. Bausch Health US, LLC.