Efinaconazole topical solution (10%) for the treatment of onychomycosis in adult and pediatric patients

References

• Thomas J, Jacobson GA, Narkowicz CK, et al. Toenail onychomycosis: an important global disease burden. J Clin Pharm Ther. 2010;35(5):497–519.
   PubMed Web of Science ®Google Scholar
• Welsh O, Vera-Cabrera L, Welsh E. Onychomycosis. Clin Dermatol. 2010;28(2):151–159.
   PubMed Web of Science ®Google Scholar
• Vlahovic TC, Joseph WS, Scher RK, et al. Diagnosis and management of onychomycosis perspectives from a joint podiatric medicine-dermatology roundtable. J Am Podiatr Med Assoc. 2016;106(2):155–162.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Stec N. Recent advances in therapies for onychomycosis and its management. F1000Res. 2019:8.
   Google Scholar
• Daniel RC. Onychomycosis: burden of disease and the role of topical antifungal treatment. J Drugs Dermatol. 2013;12(11):1263–1266.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Versteeg SG, Shear NH. Onychomycosis in the 21st century: an update on diagnosis, epidemiology, and treatment. J Cutan Med Surg. 2017;21(6):525–539.
   PubMed Web of Science ®Google Scholar
• Haneke E, Roseeuw D. The scope of onychomycosis: epidemiology and clinical features. Int J Dermatol. 1999;38(S2):7–12.
   PubMedGoogle Scholar
• Narasimha Murthy S, Wiskirchen DE, Bowers CP. Iontophoretic drug delivery across human nail. J Pharm Sci. 2007;96(2):305–311.
   PubMed Web of Science ®Google Scholar
• Tosti A, Elewski BE. Onychomycosis: practical approaches to minimize relapse and recurrence. Skin Appendage Disord. 2016;2(1–2):83–87.
   PubMed Web of Science ®Google Scholar
• Ciclopirox prescribing information [Internet]. New Jersey: Dermik Laboratories; 2006 [cited 2020 Nov 15]. Available from: https://products.sanofi.us/Penlac/Penlac.pdf.
   Google Scholar
• Tavaborole prescribing information [Internet]. New York: Anacor Pharmaceuticals, Inc; 2018. [cited 2020 Nov 15]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204427s006lbl.pdf.
   Google Scholar
• Sugiura K, Sugimoto N, Hosaka S, et al. The low keratin affinity of efinaconazole contributes to its nail pnetration and fungicidal activity in topical onychomycosis treatment. Antimicrob Agents Chemother. 2014;58(7):3837–3842.
   PubMed Web of Science ®Google Scholar
• Sakamoto M, Sugimoto N, Kawabata H, et al. Transungual delivery of efinaconazole: its deposition in the nail of onychomycosis patients and in vitro fungicidal activity in human nails. J Drugs Dermatol. 2014;13(11):1388–1392.
   PubMed Web of Science ®Google Scholar
• 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):600–608.
   PubMed Web of Science ®Google Scholar
• Bohn M, Kraemer KT. Dermatopharmacology of ciclopirox nail lacquer topical solution 8% in the treatment of onychomycosis. J Am Acad Dermatol. 2000;43(4):S57–69.
   PubMed Web of Science ®Google Scholar
• Hold KM, Bu W, Sanders V, et al. In vivo nail residence time of AN2690, a novel broad-spectrum antifungal agent in development for the topical treatment of onychomycosis. J Am Acad Dermatol. 2007;56(2):AB128.
   Web of Science ®Google Scholar
• 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):815–820.
   PubMed Web of Science ®Google Scholar
• Eichenfield LF, Elewski B, Sugarman JL, et al. Efinaconazole 10% topical solution for the treatment of onychomycosis in pediatric patients: open-label phase 4 study. J Am Acad Dermatol. 2021; 84(4)1140–1142.
   Google Scholar
• Elewski BE, Pollak RA, Pillai R, et al. Access of efinaconazole topical solution, 10%, to the infection site by spreading through the subungual space. J Drugs Dermatol. 2014;13(11):1394–1398.
   PubMed Web of Science ®Google Scholar
• Ciclopirox product monograph [Internet]. Canada: Valeant Canada LP. 2012. [cited 2020 Nov 15]. Available from: https://pdf.hres.ca/dpd_pm/00015736.PDF.
   Google Scholar
• Haria M, Bryson HM. Amorolfine. A review of its pharmacological properties and therapeutic potential in the treatment of onychomycosis and other superficial fungal infections. Drugs. 1995;49(1):103–120.
   PubMed Web of Science ®Google Scholar
• Monti D, Herranz U, Bo L D, et al. Nail penetration and predicted mycological efficacy of an innovative hydrosoluble ciclopirox nail lacquer vs. a standard amorolfine lacquer in healthy subjects. J Eur Acad Dermatol Venereol. 2013;27(2):e153–158.
   PubMed Web of Science ®Google Scholar
• Elewski BE, Aly R, Baldwin SL, et al. 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. J Am Acad Dermatol. 2015;73(1):62–69.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Fleckman P, Baran R. Ciclopirox nail lacquer topical solution 8% in the treatment of toenail onychomycosis. J Am Acad Dermatol. 2000;43(S4):S70–80.
   PubMed Web of Science ®Google Scholar
• Lauharanta J. Comparative efficacy and safety of amorolfine nail lacquer 2% versus 5% once weekly. Clin Exp Dermatol. 1992;17(S1):41–43.
   PubMedGoogle Scholar
• Efinaconazole prescribing information [Internet]. Japan: Kaken Pharmaceutical Co. 2014. [cited 2020 Nov 15]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203567s000lbl.pdf.
   Google Scholar
• Rich P, Spellman M, Purohit V, et al. Tavaborole 5% topical solution for the treatment of toenail onychomycosis in pediatric patients: results from a phase 4 open-label study. J Drugs Dermatol. 2019;18(2):190–195.
   PubMed Web of Science ®Google Scholar
• Friedlander SF, Chan YC, Chan YH, et al. Onychomycosis does not always require systemic treatment for cure: a trial using topical therapy. Pediatr Dermatol. 2013;30(3):316–322.
   PubMed Web of Science ®Google Scholar
• Terbinafine hydrochloride prescribing information [Internet]. New Jersey: Novartis. 2019. [cited 2020 Nov 15]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020539s033lbl.pdf.
   Google Scholar
• Itraconazole prescribing information [Internet]. New Jersey: Janssen Pharmaceutical Companies. 2018. [cited 2020 Nov 15]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020083s063lbl.pdf.
   Google Scholar
• Efinaconazole prescribing information [Internet]. New Jersey: Bausch Health Companies Inc. 2020. [cited 2020 Nov 15]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203567s009lbl.pdf.
   Google Scholar
• Gupta AK, Renaud HJ, Quinlan EM, et al. The growing problem of antifungal resistance in onychomycosis and other superficial mycoses. Am J Clin Dermatol. 2020;22(2):149–157.
   PubMed Web of Science ®Google Scholar
• Vlahovic, TC. A closer look at the potential of topical efinaconazole for treating onychomycosis in pediatric patients. [Internet]. Pennsylvania: HMP Global. 2020. [cited 2020 Dec 17]. Available from: https://www.podiatrytoday.com/blogged/closer-look-potential-topical-efinaconazole-treating-onychomycosis-pediatric-patients.
   Google Scholar
• Gupta AK, Mays RR, Versteeg SG, et al. Onychomycosis in children: safety and efficacy of antifungal agents. Pediatr Dermatol. 2018;35(5):552–559.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Foley KA, Mays RR, et al. Monotherapy for toenail onychomycosis: a systematic review and network meta-analysis. Br J Dermatol. 2020;182(2):287–299.
   PubMed Web of Science ®Google Scholar
• Alley MRK, Baker SJ, Beutner KR, et al. Recent progress on the topical therapy of onychomycosis. Expert Opin Investig Drugs. 2007;16(2):157–167.
   PubMed Web of Science ®Google Scholar
• Eisai Global. Oral antifungal agent Nailin capsules 100mg approved in Japan. [Internet]. Press release; 2018. [cited 2020 Nov 15]. Available from: https://www.eisai.com/news/2018/news201806.html.
   Google Scholar
• Ameen M, Lear JT, Madan V, et al. British Association of Dermatologists’ guidelines for the management of onychomycosis 2014. Br J Dermatol. 2014;171(5):937–958.
   PubMed Web of Science ®Google Scholar
• Thatai P, Sapra B. Transungual delivery: deliberations and creeds. Int J Cosmet Sci. 2014;36(5):398–411.
   PubMed Web of Science ®Google Scholar
• Kobayashi Y, Miyamoto M, Sugibayashi K, et al. Drug permeation through the three layers of the human nail plate. J Pharm Pharmacol. 1999;51(3):271–278.
   PubMed Web of Science ®Google Scholar
• Tabara K, Szewczyk AE, Bienias W, et al. Amorolfine vs. ciclopirox - lacquers for the treatment of onychomycosis. Postepy Dermatol Alergol. 2015;32(1):40–45.
   PubMed Web of Science ®Google Scholar
• 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):495–501.
   PubMed Web of Science ®Google Scholar
• Bohn M, Kraemer K. The dermatopharmacologic profile of ciclopirox 8% nail lacquer. J Am Podiatr Med Assoc. 2000;90(10):491–494.
   PubMed Web of Science ®Google Scholar
• Adis Insight drug profile. Terbinafine transungual solution [Internet]. Switzerland: Springer. Updated 2020. [cited 2020 Nov 16]. Available from: https://adisinsight.springer.com/drugs/800040728.
   Google Scholar
• Gupta AK, Surprenant MS, Kempers SE, et al. Efficacy and safety of topical terbinafine 10% solution (MOB-015) in the treatment of mild to moderate distal subungual onychomycosis: a randomized, multicenter, double-blind, vehicle-controlled phase 3 study. J Am Acad Dermatol. 2020;S0190-9622(20):31153.
   Google Scholar
• Geyer AS, Onumah N, Uyttendaele H, et al. Modulation of linear nail growth to treat diseases of the nail. J Am Acad Dermatol. 2004;50(2):229–234.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Cernea M. How effective is efinaconazole in the management of onychomycosis? Expert Opin Pharmacother. 2016;17(4):611–618.
   PubMed Web of Science ®Google Scholar
• 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):1610–1616.
   PubMed Web of Science ®Google Scholar
• Lipner SR, Scher RK. Efinaconazole in the treatment of onychomycosis. Infect Drug Resist. 2015;8:163–172.
   PubMed Web of Science ®Google Scholar
• Kircik LH. Enhancing transungual delivery and spreading of efinaconazole under the nail plate through a unique formulation approach. J Drugs Dermatol. 2014;13(12):1457–1461.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Pillai R. The presence of an air gap between the nail plate and nail bed in onychomycosis patients: treatment implications for topical therapy. J Drugs Dermatol. 2015;14(8):859–863.
   PubMed Web of Science ®Google Scholar
• Tatsumi Y, Yokoo M, Senda H, et al. Therapeutic efficacy of topically applied KP-103 against experimental tinea unguium in guinea pigs in comparison with amorolfine and terbinafine. Antimicrob Agents Chemother. 2002;46(12):3797–3801.
   PubMed Web of Science ®Google Scholar
• Zeichner JA, Stein Gold L, Korotzer A. Penetration of (14C)-efinaconazole topical solution, 10%, does not appear to be influenced by nail polish. J Clin Aesthet Dermatol. 2014;7(9):34–36.
   PubMedGoogle Scholar
• Efinaconazole topical solution product monograph [Internet]. Canada: Valeant Canada LP. 2017. [cited 2020 Nov 1]. Available from: https://pdf.hres.ca/dpd_pm/00040037.PDF.
   Google Scholar
• Jarratt M, Siu WJ, Yamakawa E, et al. Safety and pharmacokinetics of efinaconazole 10% solution in healthy volunteers and patients with severe onychomycosis. J Drugs Dermatol. 2013;12(9):1010–1016.
   PubMed Web of Science ®Google Scholar
• Efinaconazole 10% solution medical review [Internet]. Maryland: Center for Drug Evaluation and Research. 2014. [cited 2020 Dec 2]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567Orig1s000MedR.pdf.
   Google Scholar
• Eichenfield LF, Elewski B, Sugarman JL, et al. Safety, pharmacokinetics, and efficacy of efinaconazole 10% topical solution for onychomycosis treatment in pediatric patients. J Drugs Dermatol. 2020; 19(9): 867–872.
   PubMed Web of Science ®Google Scholar
• Efinaconazole 10% solution pharmacology review [Internet]. Maryland: Center for Drug Evaluation and Research. 2014. [cited 2020 Dec 2]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/203567Orig1s000PharmR.pdf.
   Google Scholar
• Del Rosso JQ, Reece B, Smith K, et al. Efinaconazole 10% solution: a new topical treatment for onychomycosis: contact sensitization and skin irritation potential. J Clin Aesthet Dermatol. 2013;6(3):20–24.
   Google Scholar
• Tschen EH, Bucko AD, Oizumi N, et al. Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol. 2013;12(2):186–192.
   PubMed Web of Science ®Google Scholar
• Iozumi K, Abe M, Ito Y, et al. Efficacy of long-term treatment with efinaconazole 10% solution in patients with onychomycosis, including severe cases: a multicenter, single-arm study. J Dermatol. 2019;46(8):641–651.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Cooper EA. Long-term efficacy and safety of once-daily efinaconazole 10% topical solution (Jublia) for dermatophyte toenail onychomycosis: an interim analysis. Skin Therapy Lett. 2021;26(1):5–10.
   PubMedGoogle Scholar
• Rodriguez DA. Efinaconazole topical solution, 10%, for the treatment of mild and moderate toenail onychomycosis. J Clin Aesthet Dermatol. 2015;8(6):24–29.
   PubMedGoogle Scholar
• Bhatia N. Managing assessments and expectations: patient responses following therapy with efinaconazole topical solution, 10%. J Drugs Dermatol. 2015;14(7):694–698.
   PubMed Web of Science ®Google Scholar
• Rich P. Efinaconazole topical solution, 10%: the benefits of treating onychomycosis early. J Drugs Dermatol. 2015;14(1):58–62.
   PubMed Web of Science ®Google Scholar
• Rosen T. Evaluation of gender as a clinically relevant outcome variable in the treatment of onychomycosis with efinaconazole topical solution 10%. Cutis. 2015;96(3):197–201.
   PubMed Web of Science ®Google Scholar
• Cook-Bolden FE, Lin T. Efinaconazole solution 10% for treatment of toenail onychomycosis in Latino patients. Cutis. 2017;99(4):286–289.
   PubMed Web of Science ®Google Scholar
• Del Rosso JQ. Onychomycosis of toenails and post-hoc analyses with efinaconazole 10% solution once-daily treatment: impact of disease severity and other concomitant associated factors on selection of therapy and therapeutic outcomes. J Clin Aesthet Dermatol. 2016;9(2):42–47.
   Google Scholar
• Vlahovic TC, Joseph WS. Efinaconazole topical, 10% for the treatment of toenail onychomycosis in patients with diabetes. J Drugs Dermatol. 2014;13(10):1186–1190.
   PubMed Web of Science ®Google Scholar
• Markinson BC, Caldwell BD. Efinaconazole topical solution, 10%: efficacy in patients with onychomycosis and coexisting tinea pedis. J Am Podiatr Med Assoc. 2015;105(5):407–411.
   PubMed Web of Science ®Google Scholar
• Elewski BE, Tosti A, Efinaconazole LT. 10% topical solution: case review of onychomycosis patients who were completely cured at week 24. Skin Appendage Disord. 2018;4(2):67–70.
   PubMed Web of Science ®Google Scholar
• Jellinek NJ, Korotzer A. Prognostic factors for complete cure following treatment of mild and moderate toenail onychomycosis with efinaconazole topical solution 10. J Drugs Dermatol. 2015;14(8):871–875.
   PubMed Web of Science ®Google Scholar
• Elewski BE, Tosti A. Risk factors and comorbidities for onychomycosis: implications for treatment with topical therapy. J Clin Aesthet Dermatol. 2015;8(11):38–42.
   PubMedGoogle Scholar
• Elewski BE, Cantrell W, Lin T. Is severity of disease a prognostic factor for cure following treatment of onychomycosis? J Drugs Dermatol. 2018;17(2):175–178.
   PubMed Web of Science ®Google Scholar
• Tosti A, Elewski BE. Treatment of onychomycosis with efinaconazole 10% topical solution and quality of life. J Clin Aesthet Dermatol. 2014;7(11):25–30.
   PubMedGoogle Scholar
• Gupta AK, Venkataraman M, Quinlan EM, et al. More than nail-deep: the effect of efinaconazole 10% treatment on the quality of life in patients with onychomycosis – a post-hoc study. Skin Appendage Disorders: In press; 2021.
   Google Scholar
• Foley K, Gupta AK, Versteeg S, et al. Topical and device-based treatments for fungal infections of the toenails. Cochrane Database Syst Rev. 2020;1(1):CD012093.
   PubMedGoogle Scholar
• Gupta AK, Sibbald R, Lynde C, et al. Onychomycosis in children: prevalence and treatment strategies. J Am Acad Dermatol. 1997;36(3 Pt 1):395–402.
   PubMed Web of Science ®Google Scholar
• Totri CR, Feldstein S, Admani S, et al. Epidemiologic analysis of onychomycosis in the San Diego pediatric population. Pediatr Dermatol. 2017;34(1):46–49.
   PubMed Web of Science ®Google Scholar
• Wang C, Cantrell W, Canavan T, et al. Successful treatment of dermatophytomas in 19 patients using efinaconazole 10% solution. Skin Appendage Disord. 2019;5(5):304–308.
   PubMed Web of Science ®Google Scholar
• Canavan TN, Bevans SL, Cantrell WC, et al. Single-center, prospective, blinded study comparing the efficacy and compatibility of efinaconazole 10% solution in treating onychomycosis with and without concurrent nail polish use. Skin Appendage Disord. 2018;5(1):9–12.
   PubMed Web of Science ®Google Scholar
• Na GY, Suh MK, Sung YO, et al. A decreased growth rate of the great toe nail observed in patients with distal subungual onychomycosis. Ann Dermatol. 1995;7(3):217–221.
   Google Scholar
• Gupta AK, Cooper EA. Long-term efficacy and safety of once-daily topical efinaconazole 10% topical solution (Jublia) for dermatophyte toenail onychomycosis: an interim analysis. Skin Therapy Lett: In press; 2021.
   Google Scholar
• FDA Adverse Event Reporting System (FAERS) Public Dashboard [Internet]. Maryland: FDA. 2020. [cited 2020 Dec 17]. Available from: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard.
   Google Scholar
• Wang Y, Lipner SR. Retrospective analysis of adverse events with topical onychomycosis medications reported to the united states food and drug administration. Arch Dermatol Res. 2020;312(8):581–586.
   PubMed Web of Science ®Google Scholar
• Glynn M, Jo W, Minowa K, et al. Efinaconazole: developmental and reproductive toxicity potential of a novel antifungal azole. Reprod Toxicol. 2015;52:18–25.
   PubMed Web of Science ®Google Scholar
• Gupta AK, Elewski BE, Rosen T, et al. Onychomycosis: strategies to minimize recurrence. J Drugs Dermatol. 2016;15(3):279–282.
   PubMedGoogle Scholar
• Gupta AK, Taborda V, Taborda P, et al. High prevalence of mixed infections in global onychomycosis. PLOS ONE. 2020;15(9): e0239648.
   PubMed Web of Science ®Google Scholar