Kerydin (tavaborole)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved July 2014

Specific Treatments:

onychomycosis of the toenails

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General Information

Kerydin (tavaborole) is an oxaborole antifungal.

Kerydin is specifically indicated for the treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. 

Kerydin is supplied as a topical solution, 5%. Kerydin should be applied to affected toenails once daily for 48 weeks. Kerydin should be applied to the entire toenail surface and under the tip of each toenail being treated. 

Clinical Results

FDA Approval

The FDA approval of Kerydin was based on two multicenter, double-blind, randomized, vehicle-controlled trials in 1,194 subjects (795 Kerydin, 399 Vehicle) 18 to 88 years of age,. Kerydin 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. Efficacy assessments were made at 52 weeks following a 48-week treatment period. The primary efficacy endpoint was "Complete Cure" at Week 52. "Complete Cure" is defined as "Completely Clear Nail" (0% clinical involvement of the target toenail) plus "Mycological Cure" (negative KOH wet mount and negative fungal culture). In the first trial, 6.5% of subjects treated with Kerydin reached the primary endpoint, compared to 0.5% of subjects treated with vehicle. In the second trial, 9.1% of subjects treated with Kerydin reached the primary endpoint, compared to 1.5% of subjects treated with vehicle.



Side Effects

Adverse effects associated with the use of Kerydin may include, but are not limited to, the following:

application site exfoliation

ingrown toenail

application site erythema

application site dermatitis

Mechanism of Action

Kerydin (tavaborole) is an oxaborole antifungal. The mechanism of action of tavaborole is inhibition of fungal protein synthesis. Tavaborole inhibits protein synthesis by inhibition of an aminoacyl-transfer ribonucleic acid (tRNA) synthetase (AARS). 

Additional Information

For additional information regarding Kerydin or onychomycosis of the toenail, please visit the Anacor website: www.anacor.com