TAVABOROLE

Tavaborole undergoes extensive metabolism. Renal excretion is the major route of elimination of the metabolites. In a clinical pharmacology trial of six healthy adult male volunteers who received a single topical application of 5% 14 C-tavaborole solution, tavaborole conjugates and metabolites were shown to be excreted primarily in the urine. The pharmacokinetics (PK) of tavaborole was investigated in 24 adult subjects with distal subungual onychomycosis involving at least 4 toenails (including ...

The efficacy and safety of tavaborole topical solution was evaluated in two multicenter, double-blind, randomized, vehicle-controlled trials. Tavaborole topical solution or vehicle was applied once daily for 48 weeks in subjects with 20% to 60% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement. A total of 1194 subjects (795 tavaborole topical solution, 399 Vehicle) 18 to 88 years of age, 82% male, 84% white, participated in these two trials. Efficacy assessments were made at 52 weeks following a 48-week treatment period. The Complete Cure effica...

Common adverse reactions occurring in ≥1% in subjects treated with tavaborole topical solution included application site exfoliation, ingrown toenail, application site erythema, and application site dermatitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Encube Ethicals Private Limited at 1-833-285-4151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed i...

None. None. (4)