Tavaborole: Phase III data

The double-blind, U.S. and Canadian Phase III Study 302 trial in 601 patients with distal subungual onychomycosis showed that a once-daily 5% topical solution of tavaborole for 48 weeks met the primary endpoint of a greater proportion of patients who achieved clinical cure at week 52 vs. vehicle-treated controls (9.1% vs. 1.5%, p<0.001). Complete cure was defined as a composite of both mycological cure and a completely clear nail, with mycological cure defined as the absence of fungus as determined by a negative potassium hydroxide examination and a negative fungal culture. Tavaborole also met the secondary endpoints of a greater proportion of patients who achieved a completely clear or almost clear (<=10% clinical involvement) nail at week 52 (27.5% vs. 14.6%, p<0.001) and who achieved mycological cure at week 52 (35.9% vs. 12.2%, p<0.001) vs. vehicle-treated controls. Additionally, a significantly greater proportion of patients receiving tavaborole achieved treatment success defined as a completely clear or almost clear nail with mycological cure at week 52 vs. vehicle-treated controls (17.9% vs. 3.9%, p<0.001). ...