Efinaconazole 10% topical solution for the treatment of onychomycosis in pediatric patients: Open-label phase 4 study

To the Editor: Onychomycosis is a chronic fungal nail infection affecting an estimated 0.35% to 5.5% of children worldwide,1Gupta A.K. Mays R.R. Versteeg S.G. et al.Onychomycosis in children: safety and efficacy antifungal agents.Pediatr Dermatol. 2018; 35: 552-559Crossref PubMed Scopus (12) Google Scholar although parents health care practitioners are hesitant use long-term systemic treatments children.2Eichenfield L.F. Friedlander S.F. Pediatric onychomycosis: emerging role topical therapy.J Drugs 2017; 16: 105-109PubMed Efinaconazole 10% solution azole approved by US Food Drug Administration treat onychomycosis patients 6 years age older.3Elewski B.E. Rich P. Pollak R. al.Efinaconazole treatment toenail two phase III multicenter, randomized, double-blind studies.J Am Acad 2013; 68: 600-608Abstract Full Text PDF (196) Scholar,4JUBLIA (Efinaconazole) Topical Solution, [package insert]. Ortho Dermatologics, Bridgewater, NJ2016Google We report here 4, open-label, multicenter study (NCT02812771) efinaconazole 16 old with distal lateral subungual onychomycosis. was administered once daily for 48 weeks, 4-week posttreatment follow-up at week 52. Participants had culture-positive mild severe 20% or more least 1 great toenail. The institutional review boards conducted according international scientific/ethical standards. All participants and/or legal guardians provided informed consent. primary objective evaluation tolerability pharmacokinetics (PK). Of 62 enrolled participants, 12 (19.4%) discontinued (withdrawal parent/guardian, n = 6; lost follow-up, 5; participant request, 1). For those who received drug (n 60; population), mean 13.4 years, 66.7% were male, 88.3% White. None treatment-emergent adverse events (TEAEs) led discontinuation (Table I). only treatment-related TEAE ingrown nail. No signals trends associated local skin reactions observed. Adverse event findings rates from this similar 52-week, 3 pivotal studies adults.3Elewski ScholarTable ITreatment-emergent summary pediatric treated (safety population)TEAEsEfinaconazole 60)Number TEAEs99Participants ?1 TEAE, (%)38 (63.3)Participants SAE, (%)1 (1.7)?The SAE pneumonia deemed unrelated treatment; moderate resolved hospitalization did not require change application.TEAEs maximum severity, (%) Mild31 (51.7) Moderate7 (11.7) Severe0Most common TEAEs (?5% Nasopharyngitis18 (30.0) Headache6 (10.0) Influenza5 (8.3) Tinea pedis†At screening baseline, tinea pedis exclusionary (severe moccasin exclusionary); total 8 (13.3%) baseline.4 (6.7) Contusion4 Nail injury4 Ingrown nail4 poisoning3 (5.0)Treatment-related nail2 (3.3)‡Eight 2 participants.SAE, Serious event; event.? application.† At baseline.‡ Eight participants. Open table new tab event. PK population included 17 (12-16 years) 50% each 4 additional toenails. 14.1 64.7% 100% In 15 evaluable data concentration-time profile relatively stable during 24-hour dosing interval. Systemic exposure low, area under curve (AUC0-24) 11.4 ng?h/mL plasma concentration (Cmax) 0.549 ng/mL. median time Cmax hours. These results comparable previously reported adults (AUC0-24, 12.15 ng?h/mL; Cmax, 0.67 ng/mL).4JUBLIA Beyond favorable expected profile, showed that substantial proportion positive responses (Fig Rates complete cure (40.0%) mycologic (65.0%) considerably higher than observed 1-year adult (complete cure: 15.2%-17.8%; 53.4%-55.2%).3Elewski Higher may be due faster growth, shorter length, duration (potentially reducing risk bed damage) versus adults. Additionally, complete/almost 52 (40.0% 41.7%, respectively) 8.5% 14.9% 1-year, open-label tavaborole 5% old.5Rich Spellman M. Purohit V. al.Tavaborole patients: study.J 2019; 18: 190-195PubMed Although have been limited design lack indicate appropriate option adolescents Medical writing editorial support Prescott Communications Group (Chicago, IL) financial Dermatologics. Dermatologics division Bausch Health US, LLC.