Naftifine

NAFTIN ® Gel is a topical antifungal drug [see Clinical Pharmacology (12.4) ] .

• NAFTIN ® Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum , Trichophyton mentagrophytes , and Epidermophyton floccosum . NAFTIN ® Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum .ICD-10: B35.3

• None. None.contraindicated

Apply a thin layer of NAFTIN ® Gel once daily to the affected areas plus an approximate ½ inch margin of healthy surrounding skin for 2 weeks. For topical use only. NAFTIN ® Gel is not for ophthalmic, oral, or intravaginal use. Apply a thin layer of NAFTIN ® Gel once daily to the affected areas plus an approximate ½ inch margin of healthy surrounding skin for 2 weeks. ( 2 ) For topical use only. NAFTIN ® Gel is not for ophthalmic, oral, or intravaginal use. ( 2 )

If redness or irritation develops with the use of NAFTIN ® Gel treatment should be discontinued. ( 5.1 ) 5.1 Local Adverse Reactions If irritation or sensitivity develops with the use of NAFTIN ® Gel, treatment should be discontinued.

The most common adverse reactions are application site reactions (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sebela Pharmaceuticals Inc. at 1-888-271-4621 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In two randomized, vehicle-controlled trials, 1143 subjects were treated with NAFTIN ® Gel versus 571 subjects treated with the vehicle. The trial subjects were 12 to 92 years old, were primarily male (76%), and were 59% Caucasian, 38% Black or African American, and 23% Hispanic or Latino. Subjects received doses once daily, topically, for 2 weeks to cover the affected skin areas plus a ½-inch margin of surrounding healthy skin. The most common adverse reactions were application site reactions which occurred at the rate of 2% in NAFTIN Gel arm versus 1% in vehicle arm. Most adverse reactions were mild in severity. In an open-label pediatric pharmacokinetics and safety trial 22 pediatric subjects 12-17 years of age with interdigital tinea pedis received NAFTIN ® Gel. The incidence of adverse reactions in the pediatric population was similar to that observed in adult population. Cumulative irritancy testing revealed the potential for NAFTIN ® Gel to cause irritation.

8.1 Pregnancy Risk Summary There are no available data on NAFTIN® Gel use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, no adverse effects on embryofetal development were seen at oral doses administered during the period of organogenesis up to 37 times the maximum recommended human dose (MRHD) in pregnant rats or subcutaneous doses administered during the period of organogenesis up to 4 times the MRHD in pregnant rats or 7 times the MRHD in pregnant rabbits ( see Data ). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Systemic embryofetal development studies were conducted in rats and rabbits. For the comparison of animal to human doses, the MRHD is set at 4 g 2% gel per day (1.33 mg/kg/day for a 60 kg individual). Oral doses of 30, 100, and 300 mg/kg/day naftifine hydrochloride were administered during the period of organogenesis to pregnant female rats.

Metabolism

In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes. Pharmacokinetic analysis of plasma samples from 32 subjects with tinea pedis treated with a mean dose of 3.9 grams NAFTIN ® Gel applied once daily to both feet for 14 days showed increased exposure over the treatment period, with a geometric mean (CV%) AUC 0-24 (area under plasma concentration-versus-time curve from time 0 to 24 hours) of 10.5 (118) ng∙hr/mL on Day 1 and an AUC 0-24 of 70 (59) ng∙hr/mL on Day 14.

• Jun 27, 2013NDANDA204286Legacy Pharma
• Jan 6, 2016ANDAANDA206901Sun Pharma Canada
• Sep 8, 2016ANDAANDA205975Sun Pharma Canada
• Apr 10, 2019ANDAANDA208201Sun Pharma Canada

1. 1Pruritus3310.0%
2. 2Blister278.2%
3. 3Skin Exfoliation267.9%
4. 4Chronic Kidney Disease247.3%
5. 5Drug Ineffective247.3%
6. 6Hypersensitivity236.9%
7. 7Rash236.9%
8. 8Erythema216.3%
9. 9Off Label Use206.0%
10. 10Diarrhoea185.4%
11. 11Pain185.4%
12. 12Renal Failure185.4%
13. 13Acute Kidney Injury154.5%
14. 14Burning Sensation133.9%
15. 15Headache123.6%

The 10 most recently updated of 14 ClinicalTrials.gov registrations naming Naftifine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Safety, Tolerability, and Pharmacokinetics of UHE-103 Cream in Subjects With Tinea Cruris and/or Tinea Pedis
  Completed · Phase 1 · Interventional · 42 enrolled · Therapeutics, Inc.
  NCT05363449updated 2024-04-10
• Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis
  Completed · Phase 1 · Interventional · 1,519 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT02335255updated 2018-09-06
• BE Study of Naftifine HCL
  Completed · Phase 3 · Interventional · 693 enrolled · Genzum Life Sciences
  NCT02633813updated 2017-05-11
• Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis
  Completed · Phase 1 · Interventional · 890 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT02132260updated 2017-05-09
• An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis
  Completed · Phase 4 · Interventional · 27 enrolled · Merz North America, Inc.
  NCT02466867updated 2016-10-28
• Pediatric Subjects With Tinea Corporis
  Completed · Phase 4 · Interventional · 230 enrolled · Merz North America, Inc.
  NCT02227290updated 2016-10-28
• Safety and Efficacy of NAFT900 in Children With Tinea Capitis
  Withdrawn · Phase 2 · Interventional · 0 enrolled · Merz North America, Inc.
  NCT02658292updated 2016-09-09
• Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
  Completed · Phase 4 · Interventional · 56 enrolled · Merz North America, Inc.
  NCT01712360updated 2016-07-14
• Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
  Completed · Phase 3 · Interventional · 65 enrolled · Merz North America, Inc.
  NCT01885156updated 2015-04-15
• Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis
  Completed · Phase 1 · Interventional · 1,053 enrolled · Sun Pharmaceutical Industries, Inc.
  NCT01580891updated 2014-05-06

Frequently asked questions

How does Naftifine work?

NAFTIN ® Gel is a topical antifungal drug [see Clinical Pharmacology (12.4) ] .

What is Naftifine used for?

According to FDA labeling, Naftifine carries indications including: NAFTIN ® Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum , Trichophyton mentagrophytes , and Epidermophyton floccosum . NAFTIN ® Gel is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Naftifine?

Naftifine is classified as Other antifungals for topical use, Allylamine Antifungal, Ergosterol Synthesis Inhibitors, Decreased Cell Wall Integrity.

What are the brand names for Naftifine?

Naftifine is marketed under brand names including Naftin.

What are the contraindications for Naftifine?

Naftifine labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.