Efficacy and safety of tavaborole topical solution, 5%, a novel boron-based antifungal agent, for the treatment of toenail onychomycosis: Results from 2 randomized phase-III studies - 17/06/15
Abstract |
Background |
Onychomycosis, a fungal nail infection, can impact quality of life.
Objective |
We sought to evaluate the efficacy and safety of tavaborole topical solution, 5% for treatment of toenail onychomycosis.
Methods |
In 2 phase-III trials, adults with distal subungual onychomycosis affecting 20% to 60% of a target great toenail were randomized 2:1 to tavaborole or vehicle once daily for 48 weeks. The primary end point was complete cure of the target great toenail (completely clear nail with negative mycology) at week 52. Secondary end points included completely or almost clear nail, negative mycology, completely or almost clear nail plus negative mycology, and safety.
Results |
Rates of negative mycology (31.1%-35.9% vs 7.2%-12.2%) and complete cure (6.5% and 9.1% vs 0.5% and 1.5%) significantly favored tavaborole versus vehicle (P ≤ .001). Completely or almost clear nail rates also significantly favored tavaborole versus vehicle (26.1%-27.5% vs 9.3%-14.6%; P < .001). Rates of completely or almost clear nail plus negative mycology (15.3%-17.9% vs 1.5%-3.9%) were significantly greater for tavaborole versus vehicle (P < .001). Application-site reactions with tavaborole included exfoliation (2.7%), erythema (1.6%), and dermatitis (1.3%).
Limitations |
Duration of follow-up is a limitation.
Conclusion |
Tavaborole demonstrates a favorable benefit-risk profile in treatment of toenail onychomycosis.
Le texte complet de cet article est disponible en PDF.Key words : antifungal agents, arthrodermataceae, nails, onychomycosis, randomized controlled trial, tavaborole
Abbreviations used : AE, FDA, KOH, TEAE, TGT, tRNA
Plan
Writing and editorial assistance was provided by Callie Grimes of Peloton Advantage, LLC, Parsippany, NJ, and was supported by Anacor Pharmaceuticals, Inc. Diane Nelson of Anacor Pharmaceuticals, Inc, provided critical review and revision of the manuscript. |
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Disclosure: Ms Baldwin and Dr Zane are employees of Anacor Pharmaceuticals, Inc. Dr Elewski has received honoraria and grants while serving as a consultant and investigator with the following companies: Anacor Pharmaceuticals, Inc; Valeant Pharmaceuticals International Inc, Bridgewater, NJ; and Meiji Seika Pharma Co, Ltd, Tokyo, Japan. Dr Aly was consultant and investigator for Anacor Pharmaceuticals, Inc. Dr González Soto was an investigator for the following companies: Anacor Pharmaceuticals, Inc; Pfizer, New York, NY; and Eli Lilly, Indianapolis, IN. Dr Rich was the principal investigator for onychomycosis studies with the following companies: Anacor Pharmaceuticals, Inc; Topica Pharmaceuticals, Los Altos, CA; Valeant Pharmaceuticals International Inc; and Viamet Pharmaceuticals Inc, Durham, NC. Dr Pollak has received grants and honoraria while serving as advisory board member, investigator, and speaker for the following companies: Anacor Pharmaceuticals, Inc; Valeant Pharmaceuticals International Inc; and Topica Pharmaceuticals. Drs Weisfeld and Wiltz were principal investigators for Anacor Pharmaceuticals, Inc. The authors were fully responsible for the content, editorial decisions, and opinions expressed in the current article. No author received an honorarium related to the development of this manuscript. |
Vol 73 - N° 1
P. 62-69 - juillet 2015 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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