FDA Approves Efinaconazole Topical Cream For Onychomycosis

The treatment was initially approved for adults >18 years old.

The US Food and Drug Administration (FDA) today approved a supplemental New Drug Application for efinaconazole (JUBLIA) topical solution, 10%, to treat onychomycosis.

The agency extended the approval of efinaconazole to treat the fungal infection of the toenails for patients >6 years old. The treatment was initially approved in June 2014 for adults >18 years old.

The approval came after investigators at Ortho Dermatologics tested the safety, pharmacokinetics, and efficacy of the treatment in patients ages 6-16 years old.

Investigators enrolled 62 patients with mild-to-severe onychomycosis in a multicenter, open-label, single-arm phase 4 study. The team aimed to evaluate the safety of efinaconazole over the 52 weeks of the study in pediatric patients with at least mild onychomycosis of the toenails. Additional objectives included the pharmacokinetics of the treatment at 4 weeks in patients 12-16 years old with onychomycosis of the toenails.

To test the efficacy, the team looked to see if patients were fungus-free (mycologic cure), had completely clear nails and were fungus-free (complete cure), and clinical efficacy (<10% toenail involvement).

The pediatric population tolerated the treatment well, the team found.

During the efficacy assessments, it was found that by the end of the study period, 65% of patients achieved mycologic cure and 36.7% were fungus-free as early as week 12. What’s more, 40% of patients had complete cure by week 52 and 50% achieved clinical efficacy by the end of the study.

Ingrown nails were the most common treatment-related side effect.

Onychomycosis has been seen in pediatrics at an increasing rate, representing 15% of all nail dystrophies in the population, according to Bill Humphries, president of Ortho Dermatologics.

“With nearly six years of real-world use since its initial approval to treat adults in 2014, (efinaconazole) has a demonstrated safety and efficacy profile, and we are pleased the FDA has recognized it as a valuable treatment option for children with toenail fungal infections,” Humphries said in a statement.

The chronic fungal nail infection can be caused by dermatophyte fungi that appears under the toenail. The condition begins as a small white or yellow spot under the nail and causes discoloration, thickening and distortion, pain, nail detachment, and surface change.

Onychomycosis can last indefinitely and could cause permanent nail damage.

The treatment has not yet been tested for children <6 years old.