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FDA Approves New Treatment for Toenail Fungal Infection — Physician’s First Watch

Medical News |
July 9, 2014

FDA Approves New Treatment for Toenail Fungal Infection

By Kelly Young

Edited by David G. Fairchild, MD, MPH, and Richard Saitz, MD, MPH, FACP, FASAM

The FDA has approved tavaborole topical solution, 5% (Kerydin) to treat onychomycosis of the toenails, the manufacturer announced Tuesday.

The solution is applied with a dropper to the affected toenails once daily for 48 weeks. In two trials of nearly 1200 people with onychomycosis without dermatophytomas or lunula involvement, 7-9% of those treated with tavaborole achieved "complete cure" at 52 weeks, compared with 0.5-1.5% of patients given topical placebo. Side effects included exfoliation, ingrown toenail, erythema, and dermatitis.

Reader Comments (3)

THADDEUS NORRIS Physician, Family Medicine/General Practice

And the 2year disease free results were?.

david tarr, dp Physician, Other, office

7% cure rate after treating for 1 year, on a daily basis, only if no lununa involvement and no dermatophytoma. Basically, they're saying if there is only a tiny bit of fungus at the distal aspect of the toenails, there's a 93% chance this expensive treatment won't work. wonder if insurances will pay for this "miracle cure".

Frank Dickerson Other Healthcare Professional, Geriatrics, Extended Care Physicians LTC

I work in two large nursing homes and see a lot of nail fungus (toenail) mainley.

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