8/1/2017
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`A Closer Look At A New Topical Option For Onychomycosis | Podiatry Today
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`A Closer Look At A New Topical Option For Onychomycosis
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`Wednesday, 10I01l14 | 28955 reads
`Kristine Hoffman DPM
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`Limited pharmacologic treatment options exist for onychomycosis, especially for patients who wish to avoid or are unable to take oral antifungal
`medication. Ciclopirox 8% nail lacquer (Penlac) has long been the only prescription strength, Food and Drug Administration (FDA) approved
`topical antifungal for the treatment of onychomycosis. Unfortunately, ciclopirox 8% nail lacquer has had very poor therapeutic outcomes, even
`with concomitant nail debridement. Over the past 10 years, following the introduction of topical ciclopirox 8% nail lacquer, there has been a
`significant lack of development of topical antifungal therapies for the treatment of onychomycosis.
`
`Recently, efinaconazole 10% solution (Jublia, Valeant Pharmaceuticals) has emerged as a promising new prescription strength topical treatment
`option for onychomycosis. Efinaconazole reportedly has cure rates comparable to oral itraconazole (Sporanox, Janssen Pharmaceuticals) and
`mycological and complete cure rates two to three times greater than that of ciclopirox 8% nail lacquer.1
`Nail debridement has been an integral part of therapeutic studies examining the efficacy of ciclopirox. Despite concomitant nail debridement, the
`efficacy of ciclopirox for the treatment of onychomycosis is very poor. Daily application of ciclopirox 8% nail lacquer in combination with nail
`debridement has shown mycological cure rates (negative culture and negative potassium hydroxide preparation) ranging from 29 to 36
`percentz-3 Complete cure rates (mycological cure and normal toenail appearance) of ciclopirox 8% nail lacquer are significantly lower, ranging
`from 5.5 to 8.5 percent.3 Given these outcomes, physicians usually reserve ciclopirox for very mild cases of onychomycosis, for palliative care,
`when patients cannot tolerate oral antifungal medication or when oral antifungals are contraindicated.3
`How Efinaconazole 10% Solution Compares To Other Antifungals For Onychomycosis
`Efinaconazole 10% solution, a new triazole topical antifungal specifically developed for onychomycosis, received FDA approval in June. Two
`parallel, double-blind, randomized phase III trials, — in which study participants applied efinaconazole daily for 48 weeks without nail
`debridement — showed mycological and complete cure rates two to three times greater than those for ciclopirox, and comparable to 12 weeks
`of oral itraconazole.1v3'5 Specifically, efinaconazole showed a 53.4 to 55.2 percent mycological cure rate at 52 weeks“!5 The complete cure rate
`with efinaconazole treatment was 15.2 to 17.8 percent. In these studies, researchers considered 40 to 45 percent of patients as having
`treatment successes. They defined treatment success as an affected target toenail area of less than 10 percent.
`Several factors, including the topical’s antifungal and physiochemical properties, theoretically contribute to the much higher efficacy of
`efinaconazole 10% solution. Efinaconazole is a broad spectrum antifungal with in vitro studies showing activity against dermatophytes, non-
`dermatophytes and yeast. Researchers have shown that efinaconazole is more potent than terbinafine, ciclopirox, itraconazole and amorolfine
`
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`Physicochemical properties that contribute to the efficacy of efinaconazole 10% solution include improved nail unit penetration and distribution to
`the entire nail apparatus. Nail unit penetration is a primary limiting factor for topical antifungal medications. Keratin binding and the rate of
`keratin bound drug release are important factors in allowing topical antifungals to penetrate the nail plate and exert their antifungal activity at the
`deeper levels of the nail plate, the nail bed and the nail matrix.1
`Research has shown efinaconazole 10% solution to have considerably lower keratin binding and faster keratin bound drug release in
`comparison to other topical antifungals.1 Alcohol, lipophilic esters and cyclomethicone in the efinaconazole solution help to create a low surface
`tension that allows application to the dry nail surface, nail folds, hyponychium and the undersurface of the nail, improving drug delivery and
`distribution.1 To date, researchers have evaluated the therapeutic efficacy of efinaconazole 10% solution without additional nail plate
`debridement. The hypothesis is that debridement may increase nail plate penetration and lead to even higher mycological and complete cure
`rates.
`In Conclusion
`
`Onychomycosis can be a difficult disorder to treat, especially in patients who cannot tolerate or are not candidates for oral antifungal
`medications. Until recently, topical treatment options were very limited with ciclopirox 8% nail lacquer being the only prescription topical
`antifungal available for the treatment of onychomycosis. Efinaconazole 10% solution is a promising new topical treatment option of
`onychomycosis with cure rates comparable to oral itraconazole, and mycological and complete cure rates 2 to 3 times greater than that of
`ciclopirox 8% nail lacquer.
`References
`
`1. Del Rosso JQ. The role of topical antifungal therapy for onychomycosis and the emergence of newer agents. J Clin Aesthet Dermatol.
`2014;7(7):10—8.
`2. De Berker D. Fungal nail disease. N Engl J Med. 2009;360(20):2108210800
`3. Gupta AK, Joseph WS. Ciclopirox 8% nail lacquer in the treatment of onychomycosis of the toenails in the United States. J Am Podiatr Med
`Assoc. 2000;90(10):495495 2
`4. Elewski BE, Rich P, Pollak R, et al. Efinaconazole 10% solution in the treatment of toenail onychomycosis: Two phase III multicenter,
`randomized, double-blind studies. J Am Acad Dermatol. 2013;68(4):600-8.
`5. Gupta AK, Elewski BE, Sugarman JL, et al. The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate
`onychomycosis: a pooled analysis of two phase 3 randomized trials. J Drugs Dermatol. 2014;13(7):815-20.
`
`6. Jo Siu WJ, Tatsumi Y, Senda H, et al. Comparison of in vitro antifungal activities of efinaconazole and currently available antifungal agents
`against a variety of pathogenic fungi associated with onychomycosis. Antimicrob Agents Chemother. 2013;57(4):1610-6.
`
`Kristine Hoffman DPM's biog
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`Comments
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`Kristine,
`Permelink Submitted by Doug Richie D.P.M. (not verified) on Thu, 10/02/2014 - 09:51
`
`Kristine,
`You report that efinaconazole has a complete cure rate "2 to 3 times greater than cyclopirox" while recognizing that cyclopirox is a relatively
`ineffective treatment. In reality, efinaconazole has a complete cure rate of less than 20 percent. With a requirement of 48 weeks of continuous
`treatment and a total cost of over $400, do you really think this new drug is a good option for patients who have only limited involvement of their
`nail plate with onychomycosis?
`reply
`
`Hi Doug - all topical
`Permalink Submitted by Kristine Hoffman (not verified) on Tue, 10/07/2014 - 15:17
`
`Hi Doug. All topical treatment options for onychomycosis continue to have low clinical cure rates. The clinical trials for efinaconazole did not use
`nail debridement so there is a potential that future studies may show higher cure rates if combined with nail debridement. As I mentioned in my
`blog, ciclopirox does remain a reasonable treatment option for patients with limited nail plate involvement. In terms of length of treatment, all
`topical treatment modalities require nearly a year of treatment. Regarding cost, efinaconazole still costs less than most laser treatments and
`currently discounts are available through certain pharmacies (Philidor Pharmacy). It is unfortunate that we don‘t have a more effective topical
`treatment option for onychomycosis but efinaconazole does show modest improvement in comparison to past treatment options.
`
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