Anacor announced that the FDA has approved Kerydin (tavaborole) 5% topical solution for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.
Kerydin is the first oxaborole antifungal approved for this indication. It inhibits protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS).
The efficacy and safety of Kerydin was studied in 2 multicenter, double-blind, randomized, vehicle-controlled trials (n=1194). Kerydin or the vehicle was applied once daily for 48 weeks in patients with 20–60% clinical involvement of the target toenail, without dermatophytomas or lunula (matrix) involvement.
In the first trial, 6.5% of subjects treated with Kerydin achieved the primary endpoint of “Complete Cure” at Week 52, vs. 0.5% of subjects treated with the vehicle. In the second trial, 9.1% of subjects treated with Kerydin reached the primary endpoint vs. 1.5% of subjects treated with the vehicle.
Kerydin topical solution will be available in an amber glass bottle containing 10mL of solution with a glass pointed-tip dropper. It is expected to launch around the end of this quarter.
For more information call (650) 543-7500 or visit Anacor.com.