“Patients and physicians have been waiting for a safe and effective treatment for onychomycosis. Millions of patients are treated several times a year with debridement because it is the safest option to improve the appearance of the nail and minimize discomfort, even though debridement doesn’t actually eliminate the fungus. Tavaborole has the potential to offer these patients an effective, safe and convenient therapy to treat this difficult infection and prevent it from spreading to other toes and skin,” said Max Weisfeld, DPM.
“Tavaborole belongs to a novel class of drugs, known as oxaboroles, and should be an exciting addition to dermatologists’ treatment options for patients who suffer from onychomycosis,” said Boni Elewski, MD, Professor of Dermatology, University of Alabama. “It is a challenging and frustrating disease, but tavaborole could be a safe and effective alternative for patients who are embarrassed by the appearance of their yellow, thickened nails and are either unwilling or unable to take oral medications to treat this condition.”
Tavaborole Phase 3 Study 301 Design
Study 301 enrolled 594 patients in the United States and Mexico with distal subungual onychomycosis, randomized two-to-one to receive either tavaborole, 5% solution, or vehicle. Eligible patients were at least 18 years of age (with no upper age limit) with a clinical diagnosis of distal subungual onychomycosis involving 20% - 60% of the total area of the target great toenail, at least 3mm of clear nail from the proximal nail fold to the most proximal visible mycotic border and positive mycology. Patients were instructed to apply tavaborole solution or vehicle to the target great toenail once daily for 48 weeks.Safety Overall, tavaborole was safe and well-tolerated across study subjects. There were no serious adverse events related to study drug. The rate of discontinuations as a result of adverse events was low (2.8% for tavaborole and 1.6% for vehicle).