Jublia (efinaconazole) / Kaken Pharma, Bausch Health, Dong-A, Mitsubishi Tanabe, Almirall - LARVOL DELTA

Comprehending the Potential of Topical Therapies for the Treatment of Onychomycosis. (PubMed, Recent Adv Drug Deliv Formul) - "The main challenge associated with topical therapy was found to be the unique structure of the nails, hampering drug penetration to the infection site and inducing fungal drug resistance. Conventional treatment methods, as well as novel techniques developed for topical therapy, like microporation, ionotophoresis, laser, and photodynamic therapy, have also been explored. Oral antifungals are most commonly used for moderate to severe onychomycosis as they provide greater cure rates, whereas topical application of antifungals is advocated for mild to moderate infections as it possesses a better safety profile. Efinaconazole solution (10%), tavaborole solution (5%), and ciclopirox nail lacquer (8%) for topical use are accepted by the Food and Drug Administration (FDA) for the management of onychomycosis. Laser treatment is approved in the United States for the short-term improvement of clear nails in fungal infections, but the clinical outcomes have not yet reached optimal..."

Journal • Infectious Disease

Emerging Antifungal-Resistant Onychomycosis in a Dermatology Clinic in Kumamoto, Japan. (PubMed, Med Mycol J) - "These strains were highly sensitive to ravuconazole, efinaconazole, and luliconazole. Fosravuconazole (n = 13) and topical efinaconazole (n = 4) could cure the disease...Non-albicans Candida isolates showed low sensitivity to itraconazole and fluconazole. Trichosporon species (n = 2) were isolated from fingernail onychomycosis."

Journal • Dermatology • Infectious Disease

Antifungal Agents' Trends of Utilization, Spending, and Prices in the US Medicaid Programs: 2009-2023. (PubMed, Antibiotics (Basel)) - "Nystatin was the most frequently utilized SFI agent, while fluconazole emerged as the most commonly prescribed agent for invasive fungal infections (IFIs)...After being introduced to the market, efinaconazole became the most expensive SFI agent over the years. Isavuconazole, the latest approved IFI medication, demonstrated sustained utilization, reimbursement, and price increases...However, this study is limited by the lack of clinical outcome data and information on off-label use. Additionally, reimbursement data may not accurately reflect actual drug prices."

Journal • Reimbursement • US reimbursement • Infectious Disease • Novel Coronavirus Disease

Efficacy and Safety of Efinaconazole 10% Topical Solution for Treatment of Onychomycosis in Older Adults: A Post Hoc Analysis of Two Phase 3 Randomised Trials. (PubMed, Mycoses) - P3 | "Efinaconazole 10% solution showed similar efficacy/safety in participants aged ≥ 65 years to the overall phase 3 population, despite potential age-related nail changes. These results demonstrate the benefits of efinaconazole in older patients with onychomycosis."

Journal • P3 data • Retrospective data • Infectious Disease

Drugs and patient's dissatisfaction reporting: From a disproportionality pharmacovigilance analysis to social pharmacology. (PubMed, Therapie) - "Despite its mandatory limitations (underreporting, selective reporting…), this study shows that pharmacovigilance data could help to understand some aspects of social pharmacology, here, patient dissatisfaction with their drug treatment."

Adverse events • Journal • Dermatology

Evaluation of the efficacy of novel topical antifungal agents against dermatophytes in North India: A prospective study. (PubMed, Curr Med Mycol) - "This study aimed to investigate the antifungal susceptibility of efinaconazole, tavaborole, luliconazole, and sertaconazole against dermatophytes isolated from cases of dermatophytosis. Tavaborole ECVs for T. mentagrophytes/interdigitale, T. tonsurans, T. rubrum, and E. floccosum were 0.5, 0.5, 0.25, and 0.016 µg/ml, respectively. The results from the present study on the in vitro performance of newer topical antifungals suggested that they hold significant promise as prospective candidates for advancing the development of new antifungal treatments for dermatophytosis."

Journal • Dermatology • Infectious Disease

Determination of Efinaconazole in Plasma using Validated LC-MS/MS Technique. (PubMed, Drug Metab Bioanal Lett) - "The validated LC-MS/MS method has exceptional sensitivity, specificity, selectivity, rapid analysis, minimal requirement of sample quantity, wide dynamic range of concentration, robustness, and reproducibility, making it an indispensable tool, especially in fields of in vitro Permeation Testing (IVPT), in vitro Release Testing (IVRT), Pharmacokinetic, Toxicology, Clinical studies, and in drug development program for the quantification of Efinaconazole."

Journal • Infectious Disease

Evaluation of Efinaconazole as a Potential Armament Against Multidrug-Resistant Yeast Candida auris (AAD 2025) - "In a proof-of-concept study, efinaconazole possessed potent inhibitory activity against C. auris that was greater than fluconazole, itraconazole, and terbinafine [5]...The effect of efinaconazole will be compared with tavaborole against 15 clinically isolated strains of C. auris (10 antifungal resistant/5 antifungal susceptible based on preliminary screening)...Investigation of all 15 C. auris strains is ongoing and full results will be presented. Results from these in vitro analyses will provide important mechanistic information on the antifungal activity efinaconazole against antifungal-resistant C. auris strains, which represent a growing threat to public health."

Infectious Disease

In Vitro Activity of 4 Topical Antifungals Against the Terbinafine-Resistant Dermatophyte Species Trichophyton indotineae (AAD 2025) - "In preliminary findings, efinaconazole demonstrated potent antifungal activity against terbinafine-resistant T. indotineae strains that was 16- and 33-fold greater than ciclopirox and tavaborole, respectively. These findings suggest that efinaconazole may be effective in the treatment of onychomycosis associated with terbinafine-resistant T. indotineae infection, though clinical evaluation is warranted."

Preclinical • Dermatology • Infectious Disease

Terbinafine-Resistant Dermatophytes Isolated in Japan. (PubMed, Med Mycol J) - "Ten strains (1 T. interdigitale strain and 9 T. rubrum strains) were found to be resistant to TBF, and susceptible to efinaconazole, itraconazole, luliconazole, and ravuconazole. We determined the sequences of the squalene epoxidase-encoding gene in 10 TBF-resistant strains, and found that all strains harbored missense and/or deletion mutations. These results indicate that the prevalence of TBF-resistant dermatophytes has increased when compared to the previous studies."

Journal • Dermatology • Infectious Disease

Efficacy and Safety of Efinaconazole 10% Topical Solution for Onychomycosis Treatment in Older Adults (SDDS 2025) - No abstract available

Clinical • Infectious Disease

Patient Characteristics, Diagnostic Testing Utilization, and Antifungal Prescribing Pattern for Onychomycosis in the USA: A Cohort Study Using DataDerm, 2016-2022. (PubMed, Skin Appendage Disord) - "Treatments were infrequently prescribed, accounting for less than one-quarter of patients (orals, terbinafine: 20.8-29.1%, fluconazole: 12.9-16.5%; topicals, efinaconazole: 3.2-13.8%); over 30% of treated patients received a combination regimen or experienced switching of treatments...Patients receiving a topical and/or oral antifungal prescription were frequently not tested to confirm the onychomycosis diagnosis (76.9%). Our findings add to a growing body of literature calling for the improvement of onychomycosis management practices."

Journal • Dermatology • Infectious Disease

Treatment of Onychomycosis and the Drug-Drug Interactions in Patients with Diabetes Mellitus and Diabetic Foot Syndrome: A Systematic Review. (PubMed, Infect Dis Rep) - "Mycological cures for mild to moderate onychomycosis were: Ageratina pichinchensis (8.6%), 8% ciclopirox (8.6% 24 weeks and 54.3% 48 weeks), 10% efinaconazole (56.5-58.33%), terbinafine (73-76.6%), itraconazole (88.2%), and laser therapy (43.8%). The antifungal treatments described in the included studies are safe for patients with well-controlled diabetes, but there are currently no studies involving patients with diabetes and multiple complications, such as diabetic foot syndrome or severe onychomycosis. Thus, further research is needed in terms of this patient profile."

Journal • Review • Cardiovascular • Diabetes • Diabetic Neuropathy • Infectious Disease • Metabolic Disorders • Nephrology • Pain • Peripheral Arterial Disease • Renal Disease

Safety and Efficacy of a 48-Month Efinaconazole 10% Solution Treatment/Maintenance Regimen: 24-Month Daily Use Followed by 24-Month Intermittent Use. (PubMed, Infect Dis Rep) - "Intermittent efinaconazole may provide suitable prophylaxis of onychomycosis relapse. Prolonged efinaconazole therapy to Month 48 appears to be safe for all ages and can continue to provide prophylaxis of onychomycosis with Intermittent Maintenance use beyond Month 24 to Month 48."

Journal • Dermatology • Infectious Disease

Epidemiological trends and healthcare disparities in onychomycosis: An analysis of the All of Us research program. (PubMed, PLoS One) - "Patients with disabilities also received different treatments when compared to able-bodied individuals, being less likely to receive ciclopirox, efinaconazole and terbinafine, but more likely to undergo debridement and trimming procedures. There are clear differences in the management of onychomycosis in the different demographic and comorbid populations that we studied. Efforts to reduce these inequalities, such as expanded health coverage, reducing communication barriers and increasing patient and physician education are needed."

Journal • Infectious Disease

Antifungal susceptibility, clinical findings, and biofilm resistance of Fusarium species causing keratitis: a challenge for disease control. (PubMed, Braz J Microbiol) - "This study evaluated the susceptibility of planktonic cells and biofilms of FSSC (n = 7) and non-FSSC (n = 7) isolates obtained from patients with keratitis from a semi-arid tropical region to amphotericin B (AMB), natamycin (NAT), voriconazole (VRZ), efinaconazole (EFZ), and luliconazole (LCZ). This study highlights the importance of mycological diagnosis and the antifungal susceptibility testing in the clinical management of FK. The ability of Fusarium to form antifungal tolerant biofilms poses a challenge to clinicians and urges the development of new antibiofilm therapeutics."

Journal • Keratitis • Mood Disorders • Ocular Inflammation • Ophthalmology • Transplantation

Genotyping and drug susceptibility profiling of Prototheca sp. strains isolated from cases of protothecosis in dogs. (PubMed, J Vet Intern Med) - "Our study identifies P. bovis as the species that most frequently causes protothecosis in dogs, which suggests the possibility of cross-species infection from other animals, especially cows. Additionally, it indicates that EFZ could be used in the treatment of infection in the colon."

Journal • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease

Efinaconazole 10% solution: a comprehensive review of its use in the treatment of onychomycosis. (PubMed, Expert Opin Pharmacother) - "Efinaconazole 10% solution is effective in diabetics and has demonstrated efficacy against dermatophytomas. Efinaconazole may be a consideration when terbinafine resistance is a concern, due to its different target of action."

Journal • Review • Dermatology • Infectious Disease • Pediatrics

Extended Use of Topical Efinaconazole Remains Safe and Can Provide Continuing Benefits for Dermatophyte Toenail Onychomycosis. (PubMed, J Fungi (Basel)) - "There is a trend of increasing mycological cure and effective cure beyond Month 12 to Month 24, without an increased safety risk. The enrolled population in this trial was significantly older than in the phase III trials, with a greater degree of onychomycosis severity; however, increased age did not appear to reduce the chance of efficacy to Month 24 in this study. Our data suggest that lack of ability to clear nail dystrophy remains a significant problem for patients, rather than any lack of efinaconazole action over long-term treatment periods."

Journal • Dermatology • Infectious Disease

Understanding Global Access to Topical Onychomycosis Therapy: A Systematic Review and Meta-Analysis. (PubMed, Mycoses) - "This study identified that access to effective topical products for onychomycosis is a global problem. This issue appeared to be due to under-representation of candida infections in pivotal clinical studies of topical onychomycosis products. A head-to-head multicentre study for topical efinaconazole or a novel broad spectrum topical agent is needed to help resolve these access problems."

Clinical • Journal • Retrospective data • Review • Candidiasis • Infectious Disease

Concealing Meets Healing in the Treatment of Toenail Onychomycosis: A Review of Concurrent Nail Polish Use with Topical Efinaconazole 10% Solution. (PubMed, J Clin Aesthet Dermatol) - "Only four small studies have assessed nail penetration and efficacy of efinaconazole 10% solution with concurrent nail polish use. Efinaconazole 10% solution demonstrated efficacy in the treatment of toenail onychomycosis among participants concurrently using toenail polish, with no visible impact on gel-polished nails."

Journal • Review • Infectious Disease

An efficient gene targeting system using Δku80 and functional analysis of Cyp51A in Trichophyton rubrum. (PubMed, AMB Express) - "The expression of cyp51A mRNA was induced by the addition of the azole antifungal drug efinaconazole, whereas no such induction was detected for cyp51B, suggesting that Cyp51A functions as an azole-responsive Cyp51 isozyme...The minimum inhibitory concentration for several azole drugs of this strain was reduced, suggesting that dermatophyte Cyp51A contributes to the tolerance for azole drugs. These findings suggest that an efficient gene targeting system using Δku80 in T. rubrum is applicable for analyzing genes encoding drug targets."

Journal • Dermatology

Photon-Induced Photo-Acoustic Streaming vs. Shock Wave-Enhanced Emission Photo-Acoustic Streaming-The Effect of Three Final Irrigation Protocols on the Bond Strength of an Individually Formed Fiber Post. (PubMed, Dent J (Basel)) - "In the first group, the irrigants were not activated, while in the second and third group, LAI was adopted using PIPS and SWEEPS protocols (Lightwalker from Fotona, Ljubliana, Slovenia)...Concerning the push-out test, the SWEEPS group showed superior shear stress in comparison to the other two groups (13.45 ± 4.29 MPa); the CONV group was inferior, with shear tension values of 8.31 ± 4.67 MPa. (4) It can be stated that the SWEEPS and PIPS protocols resulted in considerably higher fiber post retention than the conventional method, whereas the SWEEPS protocol was superior to the PIPS protocol."

Journal • Musculoskeletal Diseases • Orthopedics

Transungual Penetration and Antifungal Activity of Prescription and Over-the-Counter Topical Antifungals: Ex Vivo Comparison. (PubMed, Dermatol Ther (Heidelb)) - "Among all antifungals tested, the ability to penetrate human toenails to inhibit growth of both T. rubrum and T. mentagrophytes was greatest for efinaconazole, followed by tavaborole. These results indicate superior transungual penetration of efinaconazole compared to the other antifungals, suggesting lower keratin binding in the nail."

Journal • Preclinical • Infectious Disease

Impact of new antifungal medications on onychomycosis prescriptions and costs in Japan: A nationwide claims database study. (PubMed, J Dermatol) - "We analyzed the annual prescription volumes and medical costs of four antifungal medications: efinaconazole, luliconazole, fosravuconazole, and terbinafine. The substantial increase in medical costs also highlights the economic burden of onychomycosis and the need for cost-effective treatment strategies. This study provides valuable insights into the real-world prescription trends and medical costs of onychomycosis treatment in Japan, suggesting an opportunity to assess potential gaps between guideline recommendations and clinical practice."

Claims database • Journal • Dermatology • Infectious Disease