• 1

    Scher RK, Coppa LM: Advances in the diagnosis and treatment of onychomycosis. Hosp Med 34: 11, 1998.

  • 2

    Gupta AK, Jain HC, Lynde CW, et al: Prevalence and epidemiology of onychomycosis in patients visiting physicians' offices: a multicenter Canadian survey of 15,000 patients. J Am Acad Dermatol 43: 244, 2000.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 3

    Scher RK: Onychomycosis: therapeutic update. J Am Acad Dermatol 40: S21, 1999.

  • 4

    Elewski BE, Charif MA, Daniel CR III: Onychomycosis,” in Nails: Diagnosis, Treatment, Surgery, 2nd Ed, edited by RK Scher, Daniel CR III, p 151, WB Saunders, Philadelphia, 1997.

    • Search Google Scholar
    • Export Citation
  • 5

    Kaur R, Kashyap B, Bhalla P: Onychomycosis: epidemiology, diagnosis and management. Indian J Med Microbiol 26: 108, 2008.

  • 6

    Seebacher C, Brasch J, Abeck D, et al: Onychomycosis. Mycoses 50: 321, 2007.

  • 7

    Crissey JT: Common dermatophyte infections: a simple diagnostic test and current management. Postgrad Med 103: 191, 1998.

  • 8

    Elewski BE: Onychomycosis: treatment, quality of life, and economic issues. Am J Clin Dermatol 1: 19, 2000.

  • 9

    Niewerth M, Korting HC: Management of onychomycoses. Drugs 58: 285, 1999.

  • 10

    Drake LA, Patrick DL, Fleckman P, et al: The impact of onychomycosis on quality of life: development of an international onychomycosis-specific questionnaire to measure patient quality of life. J Am Acad Dermatol 1: 189, 1999.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 11

    Salgo PL, Daniel CR, Gupta AK, et al: Onychomycosis disease management. Med Crossfire J Debates Peer Exchange Insights Med 4: 1, 2003.

  • 12

    Roberts DT: Onychomycosis: current and future challenges. Br J Dermatol 141 (suppl 56): 1, 1999.

  • 13

    Baran R, Sigurgeirsson B, de Berker D, et al: A multicentre, randomized, controlled study of the efficacy, safety and cost-effectiveness of a combination therapy with amorolfine nail lacquer and oral terbinafine compared with oral terbinafine alone for the treatment of onychomycosis with matrix involvement. Br J Dermatol 157: 149, 2007.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 14

    Baran R, Kaoukhov A: Topical antifungal drugs for the treatment of onychomycosis: an overview of current strategies for monotherapy and combination therapy J Eur Acad Dermatol Venereol 19: 21, 2005.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 15

    Lecha M, Effendy I, Feuilhade de Chauvin M, et al: Treatment options: development of consensus guidelines. J Eur Acad Dermatol Venereol 19 (suppl 1): 25, 2005.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 16

    Murdan S: Drug delivery to the nail following topical application. Int J Pharm 236: 1, 2002.

  • 17

    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 57: 1610, 2013.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 18

    Tasumi Y, Nagashima M, Shibanushi T, et al: Mechanism of antifungal action of efinaconazole, a novel triazole agent. Antimicrob Agents Chemother 57: 2405, 2013.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 19

    Tschen E, Bucko A, Oizumi H, et al: Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2 multicenter, randomized, double-blind study. J Drugs Dermatol 12: 186, 2013.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 20

    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 68: 600, 2013.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 21

    Gupta AK, Joseph WS: Ciclopirox 8% nail lacquer in the treatment of onychomycosis of the toenails in the United States. JAPMA 90: 495, 2000.

    • Search Google Scholar
    • Export Citation
  • 22

    Lamisil (terbinafine HCl) [package insert], Novartis Pharmaceuticals Corp, East Hanover, NJ, 2012.

  • 23

    Sporanox (itraconazole) [package insert], Janssen Pharmaceuticals Inc, Titusville, NJ, 2012.

  • 24

    Elewski BE, Ghannou MA, Mayser P, et al: Efficacy, safety and tolerability of topical terbinafine nail solution in patients with mild-to-moderate toenail onychomycosis: results from three randomized studies using double-blind vehicle-controlled and open-label active-controlled designs. J Eur Acad Dermatol Venereol 27: 287, 2013.

    • Crossref
    • PubMed
    • Search Google Scholar
    • Export Citation
  • 25

    Epstein E: How often does oral treatment of toenail onychomycosis produce a disease-free nail? an analysis of published data. Arch Dermatol 134: 1551, 1998.

    • Crossref
    • Search Google Scholar
    • Export Citation
  • 26

    Sigurgeirsson B, Billstein S, Rantanen T, et al: LION Study: efficacy and tolerability of continuous terbinafine (Lamisil) compared to intermittent itraconazole in the treatment of toenail onychomycosis: Lamisil vs itraconazole in onychomycosis. Br J Dermatol 141 (suppl): 5, 1999.

    • Crossref
    • Search Google Scholar
    • Export Citation

Efinaconazole 10% Solution in the Treatment of Onychomycosis of the Toenails

Warren S. Joseph Roxborough Memorial Hospital, Philadelphia, PA.

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Tracey C. Vlahovic Temple University School of Podiatric Medicine, Philadelphia, PA.

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Radhakrishnan Pillai Valeant Pharmaceuticals, Petaluma, CA.

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Jason T. Olin Valeant Pharmaceuticals, Petaluma, CA.
Valeant Pharmaceuticals North America LLC, Bridgewater, NJ.

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Background

Efinaconazole 10% solution is a new triazole antifungal agent developed for the topical treatment of onychomycosis. This article reviews the pooled results of the two pivotal clinical trials of this drug that have been performed in the United States, Canada, and Japan.

Methods

The two studies of 1,655 patients were both double-blind, vehicle-controlled, parallel-group, randomized, multicenter studies designed to determine the efficacy and safety of efinaconazole 10% solution in the treatment of mild-to-moderate onychomycosis of the toenails caused by dermatophytes. Treatment was provided once daily for 48 weeks, and the primary end point was at week 52.

Results

The combined results show a 56% mycologic cure rate compared with 17% for vehicle at week 52. Clinical treatment success was achieved in 43% of patients treated with efinaconazole 10% solution at follow-up (week 52). Clinical treatment success was achieved in 47% of patients. As expected for a topical agent, the use of efinaconazole 10% solution was found to be safe, with mild, transient irritation at the site of application reported as the most common adverse event.

Conclusions

The efficacy and safety profile of efinaconazole 10% solution suggests that it may represent an important advance in the topical treatment of onychomycosis. Further studies will help us better understand the role of this agent for the treatment of this widespread podiatric medical condition.

Corresponding author: Warren S. Joseph, DPM, Roxborough Memorial Hospital, 5800 Ridge Ave, Philadelphia, PA 19128. (E-mail: wsjoseph@comcast.net)