Treat toenail onychomycosis with KERYDIN®—the first and only approved boron-based antifungal1-3

Boron technology: smart science for effective binding capacity and selectivity for specific fungal targets2

  • Molecular size, shape, and weight result in geometry that may provide greater interaction with target site1-3
  • Active against most strains of Trichophyton rubrum and Trichophyton mentagrophytes1

Trichophyton mentagrophytes and Trichophyton rubrum strains from isolates collected in the clinical trials have not demonstrated resistance following repeated exposure to tavaborole1

  • Reaches the site of infection1,4
  • Antifungal activity not affected by the presence of keratin*4
*
The clinical significance of these ex vivo data has not been established.
Boron possesses molecular size, shape, and weight that provide greater interaction with the target site

References: 1. KERYDIN® topical solution, 5% [Prescribing Information, 2015]. Anacor Pharmaceuticals, Inc. 2. Del Rosso JQ, Plattner JJ. From the test tube to the treatment room: fundamentals of boron-containing compounds and their relevance to dermatology. J Clin Aesthet Dermatol. 2014;7(2):13-21. 3. Elewski BE, Tosti A. Tavaborole for the treatment of onychomycosis. Expert Opin Pharmacother. 2014;15(10):1439-1448. 4. Data on file, Fougera.

Boron: could it reshape dermatologic therapy?

A naturally occurring element...

  • An essential trace element for plants1
  • Found in fruits, leafy vegetables, nuts, and legumes1
  • 1.0 mg to 13 mg per day is considered a safe range for human consumption2
Boron

For illustrative purposes only.

…with potential clinical relevance3

  • May allow for changes in molecular size and shape to help target and reach key proteins4
  • May interact differently with target sites than do traditional carbon-based compounds3
  • May reduce off-target binding and improve selectivity to target proteins4

— Based on the activity of the boron-containing molecule4

Boron possesses molecular size, shape, and weight that provide greater interaction with the target site

References: 1. Das BC, Thapa P, Karki R, et al. Boron chemicals in diagnosis and therapeutics. Future Med Chem. 2013;5(6):653-676. 2. World Health Organization. Trace elements in human nutrition and health. http://www.who.int/nutrition/publications/micronutrients/9241561734/en/. Published 1996. Accessed March 20, 2017. 3. Hunter P. Not boring at all: boron is the new carbon in the quest for novel drug candidates. EMBO Reports. 2009;10(2):125-128. 4. Del Rosso JQ, Plattner JJ. From the test tube to the treatment room: fundamentals of boron-containing compounds and their relevance to dermatology. J Clin Aesthet Dermatol. 2014;7(2):13-21.

KERYDIN® works differently, based on its antifungal MOA1,2

Fungal protein-synthesis inhibitor

  • KERYDIN® interrupts the building of peptide chains, which inhibits fungal protein synthesis3

KERYDIN® mechanism of action: inhibition of protein synthesis

Because of the boron atom, tRNA cannot complete the amino acid transfer to the ribosome, so protein synthesis is effectively blocked

Tavaborole’s structure contains a boron atom, which enables it to trap tRNA within the editing site of Leucyl-tRNA synthetase (LeuRS).3

  1. LeuRS loads amino acid onto the tRNA at the catalytic site.3
  2. LeuRS checks accuracy of aminoacyl-tRNA at the editing site.3
  3. Tavaborole targets fungal cytoplasmic LeuRS by binding to the editing site together with tRNA. There, tRNA is trapped.3
  4. Because tRNA cannot complete the amino acid transfer to the ribosome for assembly, protein synthesis is effectively blocked.3

Tavaborole’s structure contains a boron atom, which enables it to trap tRNA within the editing site of Leucyl-tRNA synthetase (LeuRS).3

  1. LeuRS loads amino acid onto the tRNA at the catalytic site.3
  1. LeuRS checks accuracy of aminoacyl-tRNA at the editing site.3
  2. Tavaborole targets fungal cytoplasmic LeuRS by binding to the editing site together with tRNA. There, tRNA is trapped.3
  1. Because tRNA cannot complete the amino acid transfer to the ribosome for assembly, protein synthesis is effectively blocked.3

References: 1. KERYDIN® topical solution, 5% [Prescribing Information, 2015]. Anacor Pharmaceuticals, Inc. 2. Elewski BE, Tosti A. Tavaborole for the treatment of onychomycosis. Expert Opin Pharmacother. 2014;15(10):1439-1448. 3. Rock FL, Mao W, Yaremchuk A, Tukalo M, et al. An antifungal agent inhibits an aminoacyl-tRNA synthetase by trapping tRNA in the editing site. Science. 2007;316(22):1759-1761.

Treat toenail onychomycosis with proven efficacy

Results are clear: with KERYDIN®, the body may grow a healthy nail over time1,2

  • A toenail only grows about 1 mm a month—so it can take 12 to 18 months to grow out completely1,3

Efficacy results: 1-year studies(see study design below)

Toenail with 0% clinical involvement and mycologic cure

Example of toenail with 0% clinical involvement and mycologic cure at 52 weeks
Example of toenail with 0% clinical involvement and mycologic cure at 52 weeks
Example of toenail with 0% clinical involvement and mycologic cure at 52 weeks
Example of toenail with 0% clinical involvement and mycologic cure at 52 weeks
Example of toenail with 0% clinical involvement and mycologic cure at 52 weeks

Actual patients who responded to treatment during clinical trials. Individual results may vary.

*
The efficacy and safety of KERYDIN® were evaluated in 2 multicenter, double-blind, randomized, vehicle-controlled trials. A total of 1194 adult patients with 20% to 60% clinical involvement of the target great toenail (TGT) applied KERYDIN® (n=795) or vehicle (n=399) once daily for 48 weeks.

Primary efficacy endpoint: Complete Cure (0% clinical involvement plus negative KOH wet mount and fungal culture) of the TGT at Week 52 (P=0.001, Trial 1; P<0.001, Trial 2).

Secondary endpoints: Complete or Almost Complete Cure (<10% affected TGT involved and negative KOH wet mount and fungal culture) of the TGT at Week 52 (P<0.001 for both trials) and Mycologic Cure (negative KOH wet mount and fungal culture) of the TGT at Week 52 (P<0.001 for both trials).2,4

Toenail with ≤10% clinical involvement and mycologic cure

Example of toenail with <10% clinical involvement and mycologic cure at 52 weeks
Example of toenail with <10% clinical involvement and mycologic cure at 52 weeks
Example of toenail with <10% clinical involvement and mycologic cure at 52 weeks
Example of toenail with <10% clinical involvement and mycologic cure at 52 weeks

Actual patients who responded to treatment during clinical trials. Individual results may vary.

*
The efficacy and safety of KERYDIN® were evaluated in 2 multicenter, double-blind, randomized, vehicle-controlled trials. A total of 1194 adult patients with 20% to 60% clinical involvement of the target great toenail (TGT) applied KERYDIN® (n=795) or vehicle (n=399) once daily for 48 weeks.

Primary efficacy endpoint: Complete Cure (0% clinical involvement plus negative KOH wet mount and fungal culture) of the TGT at Week 52 (P=0.001, Trial 1; P<0.001, Trial 2).

Secondary endpoints: Complete or Almost Complete Cure (<10% affected TGT involved and negative KOH wet mount and fungal culture) of the TGT at Week 52 (P<0.001 for both trials) and Mycologic Cure (negative KOH wet mount and fungal culture) of the TGT at Week 52 (P<0.001 for both trials).2,4

Defined as negative potassium hydroxide (KOH) wet mount and negative culture

*
The efficacy and safety of KERYDIN® were evaluated in 2 multicenter, double-blind, randomized, vehicle-controlled trials. A total of 1194 adult patients with 20% to 60% clinical involvement of the target great toenail (TGT) applied KERYDIN® (n=795) or vehicle (n=399) once daily for 48 weeks.

Primary efficacy endpoint: Complete Cure (0% clinical involvement plus negative KOH wet mount and fungal culture) of the TGT at Week 52 (P=0.001, Trial 1; P<0.001, Trial 2).

Secondary endpoints: Complete or Almost Complete Cure (<10% affected TGT involved and negative KOH wet mount and fungal culture) of the TGT at Week 52 (P<0.001 for both trials) and Mycologic Cure (negative KOH wet mount and fungal culture) of the TGT at Week 52 (P<0.001 for both trials).2,4

See below for complete study design and complete definition of variables.

Studied in a broad range of patients (aged 18 to 88 years)2
Studied in patients with 20% to 60% target toenail involvement2
Results achieved without debridement5
Nail trimming was limited to within 1 mm distal to the hyponychium4

Study designed to include real-world patients

References: 1. Elewski BE. Onychomycosis: pathogenesis, diagnosis, and management. Clin Microb Rev. 1998;11(3):415-429. 2. KERYDIN® topical solution, 5% [Prescribing Information, 2015]. Anacor Pharmaceuticals, Inc. 3. Yaemsiri S, Hou N, Slining MM, He K. Growth rate of human fingernails and toenails in healthy American young adults. J Eur Acad Dermatol Venereol. 2010;24(4):420-423. 4. 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. 5. Gupta AK, Daigle D. Tavaborole (AN-2690) for the treatment of onychomycosis of the toenail in adults. Expert Rev Anti Infect Ther. 2014;12(7):735-742.

Prescribe the drop-on toenail fungus treatment

Straightforward application may help patients fit treatment into their daily routines

  • KERYDIN® is a clear and colorless topical solution1
  • Apply KERYDIN® topical solution to cover the entire nail surface and under the tip of each affected toenail once daily for 48 weeks1

— Use on clean and dry nails—no waiting time required when applied after bathing

— Dries in a couple of minutes1

  • The impact of nail polish or other cosmetic nail products on the efficacy of KERYDIN® has not been evaluated1
  • The dropper helps patients get the medication where it needs to go—over, under, and through the nail1

Here is what your patients need to know about applying KERYDIN®

Before using KERYDIN® for the first time: Remove and discard bottle cap and package wrapping. Insert the dropper into the KERYDIN® bottle.1

Squeeze the top to get KERYDIN® into the dropper

Step 1: Squeeze the top to get KERYDIN® into the dropper.

Apply KERYDIN® under the toenails

Step 4: Also apply KERYDIN® under the tip of the toenail. Use the dropper tip to spread KERYDIN® under the tip of the toenail. Repeat Steps 1 through 4 for each affected toenail.* Allow a couple of minutes for toenails to dry completely.

Hold the dropper over the affected toenail and apply one or more drops

Step 2: Hold the dropper over the affected toenail and apply one or more drops to cover the nail.

Insert the dropper back into the bottle and screw cap on tightly

Step 5: Insert the dropper back into the bottle, screw it on tightly, and wash your hands.

Spread KERYDIN® over the whole toenail

Step 3: Using the dropper tip, spread KERYDIN® over the whole toenail.

*Use a tissue to wipe any excess solution from the surrounding skin. Do not wipe KERYDIN® off of your toenails.

Please refer to the KERYDIN® Medication Guide to read the full Instructions for Use.

Step 1: Squeeze the top to get KERYDIN® into the dropper.

Step 2: Hold the dropper over the affected toenail and apply one or more drops to cover the nail.

Step 3: Using the dropper tip, spread KERYDIN® over the whole toenail.

Step 4: Also apply KERYDIN® under the tip of the toenail. Use the dropper tip to spread KERYDIN® under the tip of the toenail. Repeat Steps 1 through 4 for each affected toenail.* Allow a couple of minutes for toenails to dry completely.

Step 5: Insert the dropper back into the bottle, screw it on tightly, and wash your hands.

*Use a tissue to wipe any excess solution from the surrounding skin. Do not wipe KERYDIN® off of your toenails.

Please refer to the KERYDIN® Medication Guide to read the full Instructions for Use.

KERYDIN® is available in two bottle sizesKERYDIN® is available in two bottle sizes

Reference: 1. KERYDIN® topical solution, 5% [Prescribing Information, 2015]. Anacor Pharmaceuticals, Inc.

Additional prescribing considerations for KERYDIN®

  • Topical application reduces systemic exposure1,2
  • No liver function testing required2
  • No CYP450-mediated drug interactions expected*1
  • No contraindications1
*
In vitro studies showed no effect on CYP450 enzymes.1

In clinical trials with KERYDIN®:


Adverse Reactions Occurring in ≥1% of KERYDIN® Topical Solution, 5%-Treated Subjects and at a Greater Frequency Than Observed With Vehicle1

Preferred Term KERYDIN®
n=791
Vehicle
n=395
Application site exfoliation 21 (2.7%) 1 (0.3%)
Ingrown toenail 20 (2.5%) 1 (0.3%)
Application site erythema 13 (1.6%) 0 (0%)
Application site dermatitis 10 (1.3%) 0 (0%)

References: 1. KERYDIN® topical solution, 5% [Prescribing Information, 2015]. Anacor Pharmaceuticals, Inc. 2. Data on file, Fougera.

Important Safety Information

KERYDIN® is for topical use only and not for oral, ophthalmic, or intravaginal use. The most commonly reported adverse events involved skin reactions in the application area, including exfoliation, ingrown toenail, erythema, and dermatitis.

Safety and effectiveness have not been established in pregnant or breastfeeding women or pediatric patients.

See Full Prescribing Information for KERYDIN®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Indication

KERYDIN® is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Important Safety Information

KERYDIN® is for topical use only and not for oral, ophthalmic, or intravaginal use. The most commonly reported adverse events involved skin reactions in the application area, including exfoliation, ingrown toenail, erythema, and dermatitis.

Safety and effectiveness have not been established in pregnant or breastfeeding women or pediatric patients.

See Full Prescribing Information for KERYDIN®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Indication

KERYDIN® is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Rotate your phone for Important Safety Information.