The Efficacy and Safety of Efinaconazole 10% Solution for Treatment of Mild to Moderate Onychomycosis: A Pooled Analysis of Two Phase 3 Randomized Trials
July 2014 | Volume 13 | Issue 7 | Original Article | 815 | Copyright © 2014
Aditya K. Gupta MD PhD FRCPC,a,b Boni E. Elewski MD,c Jeffrey L. Sugarman MD PhD,d
Chikara Ieda,e Hideki Kawabata MS,e Robert Kang PhD,f Radhakrishnan Pillai PhD,g
Jason T. Olin PhD,f and Shinichi Watanabe MD PhDh
aDepartment of Medicine, University of Toronto, Toronto, Canada
bMediprobe Research Inc. London, Canada
cDepartment of Dermatology, University of Alabama at Birmingham School of Medicine, Birmingham, AL
dDepartment of Dermatology, University of California, San Francisco, CA
eKaken Pharmaceutical Co Ltd, Tokyo, Japan
fValeant Pharmaceuticals North America LLC, Bridgewater, NJ
gDow Pharmaceutical Sciences Inc., Petaluma, CA
hDepartment of Dermatology, Teikyo University School of Medicine, Tokyo, Japan
BACKGROUND: Onychomycosis is a fungal infection of the nail apparatus that can be challenging to treat due to the modest efficacy of
existing antifungal therapies and a high rate of relapse and recurrence.
OBJECTIVES: To investigate the efficacy and safety of efinaconazole 10% solution in pooled Phase III clinical trial participants with mild to moderate onychomycosis.
METHODS: Phase III clinical trials data from NCT01008033 and NCT01007708 were pooled. Efficacy analysis for the primary and secondary outcome variables was conducted using the mITT population and analysed using Cochran-Mantel-Haenszel tests. Subgroup analysis was conducted for prognostic factors that may affect drug efficacy. Safety analysis was conducted on all recipients of a single drug dose.
RESULTS: Efinaconazole 10% nail solution was superior to vehicle for all primary and secondary outcome measures assessed. Complete cure was 18.5% vs 4.7% P<0.001 [mITT] and mycological cure was 56.3% vs 16.6%, P<0.001 [mITT]. Complete or almost complete cure and treatment success were achieved in 27.7% and 47.2% compared to 7.9% and 18.2% with vehicle, respectively (P<0.001 [mITT]). In all subgroups, efinaconazole 10% solution had statistically higher cures rates compared to vehicle. Higher complete cure rates were observed in women and individuals with mild disease (≤33% involvement), but not in any other subgroup assessed. Treatment associated adverse events in the efinaconazole 10% solution group were similar to vehicle and limited to local site reactions (2%).
CONCLUSIONS: The findings from this pooled analysis suggest that efinaconazole 10% solution may become the preferred topical agent for mild to moderate onychomycosis.
J Drugs Dermatol. 2014;13(7):815-820.
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Efinaconazole 10% solution is an antifungal drug that recently completed parallel Phase III clinical trials for the treatment of distal and lateral subungual onychomycosis (DLSO).1 Efinaconazole is a triazole derivative that inhibits ergosterol biosynthesis with a high in vitro efficacy.2,3 It has been formulated in a topical solution specifically designed for the treatment of onychomycosis. The initial report on the parallel Phase III trials confirmed that efinaconazole 10% solution is an effective and safe option for the topical treatment of DLSO.1 It received Health Canada approval on October 2, 2013.
Efinaconazole 10% solution was formulated to address the challenges of treating onychomycosis. The current oral therapies have moderate efficacy,4–6 but they are associated with systemic adverse events and drug interactions.7–9 Onychomycosis has an increased prevalence in males,10 the elderly,11 diabetics,12 individuals with poor peripheral perfusion,13 and immunocompromised patients.14 These patients often undergo polypharmacy, putting them at increased risk for adverse events, which excludes a subset of the population who are the most vulnerable to complications like diabetic foot syndrome and systemic infections.15–17 Topical therapy may be preferred, as it decreases the systemic exposure of the drug; however, current topical options have not proven as effective as oral drugs due to issues of penetrance through the nail plate.18 The formulation of efinaconazole 10% solution was developed specifically to increase uptake of the drug.