RALEIGH, N.C.--(BUSINESS WIRE)--Merz Dermatology, a division of Merz North America (US affiliate of the global Merz Pharma Group) announced today that it will be presenting clinical data at the upcoming American Academy of Dermatology meeting in San Francisco on Naftin® (naftifine HCl) Gel 2%. The clinical data, titled “Clinical Benefit and Assessment of Pharmacokinetic Profile of Naftifine Hydrochloride Gel 2%: An Open-Label, Multi-Center, Multiple-Application Study in Pediatric Subjects with Tinea Pedis” demonstrates the efficacy of Naftin® (naftifine HCl) Gel 2% in treating pediatric patients with tinea pedis, the most common antifungal infection in the world.
“Tinea pedis, or athlete’s foot, can be particularly uncomfortable for children, and we are pleased to provide physicians with a new treatment option for their younger patients,” stated Greg Besase, Vice President and US Head of Dermatology for Merz North America. “Merz remains committed to finding new ways to improve patient health and expand our leadership in antifungal therapy. Naftin® remains the #1 topical antifungal brand in the U.S.1 and we are pleased to showcase additional clinical data that demonstrates its efficacy and safety in patients under the age of 18.”
In the study, authored by Drs. Verma, Olayinka and Fleischer, twenty-two subjects, between the ages of 12 to 17, were treated with Naftin® (naftifine HCl) Gel 2% once daily for two weeks. Efficacy was assessed at day 7, 14 and 28 (two weeks after last application). Naftin® (naftifine HCl) Gel 2% was found to be well-tolerated and safe, with a clinical benefit being shown through the treatment period, but with many of the subjects continuing to improve beyond the two week period.
The study is being presented at the Annual Meeting of the American Academy of Dermatology on Sunday, March 22nd at 10:50 AM Pacific Standard Time, during an E-Poster presentation.
About Naftin®
Naftin® Cream, 2% is an allyamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum in patients 12 years of age and older. Naftin® Gel, 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. Naftin® (naftifine HCl) Gel 2% and Naftin® (naftifine HCl) Cream 2% are applied topically once a day for 2 weeks. In clinical trials with Naftin® Gel 2%, the most common adverse reactions (2%) were application site reactions. In clinical trials with Naftin® Cream, 2%, the most common adverse reaction (≥1%) was pruritus. If redness or irritation develops with the use of either Naftin® Cream, 2% or Naftin® Gel, 2%, treatment should be discontinued.
Please see brief summary Full Prescribing Information for Naftin® Cream, 2% and Naftin® Gel, 2% below, or find Full Prescribing Information at www.naftin.com.
About Merz Dermatology
Merz Dermatology is a division of Merz North America, a specialty healthcare company that develops and commercializes treatment solutions in aesthetics, dermatology and neurosciences in the U.S. and Canada. By developing products that improve patients’ health and help them to live better, feel better and look better, Merz will continue to make significant contributions to the well-being of individuals around the world. Merz Dermatology is committed to providing high quality products and outstanding service to physicians in the fields of medical dermatology and podiatry. Merz Dermatology‘s flagship brand, Naftin® (naftifine
HCl), remains the #1 topical antifungal brand prescribed by dermatologists and
podiatrists in the U.S.1 Merz Dermatology is an important contributor to the U.S. dermatology and podiatry space, offering a well-balanced product portfolio that includes the Naftin® (naftifine HCl) family of products, Aluvea™ (Urea 39%) Cream, and Topicort® 0.05% (Desoximetasone) Cream and Ointment. For more information about Merz Dermatology and their U.S. product portfolio, please visit www.merzusa.com.
Brief Summary of Full Prescribing Information for Naftin Cream, 2%
INDICATIONS AND USAGE: NAFTIN (naftifine hydrochloride) Cream, 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organism Trichophyton rubrum in patients 12 years of age and older.
CONTRAINDICATIONS: None.
WARNINGS AND PRECAUTIONS: If redness or irritation develops with the use of NAFTIN Cream, 2% treatment should be discontinued.
Information for Patients:
1. NAFTIN (naftifine hydrochloride) Cream, 2% is for topical use only. NAFTIN (naftifine hydrochloride) Cream, 2% is not intended for intravaginal or ophthalmic use.
2. If irritation or sensitivity develops with the use of NAFTIN (naftifine hydrochloride) Cream, 2% treatment should be discontinued and appropriate therapy instituted. Patients should be directed to contact their physician if these conditions develop following use of NAFTIN (naftifine hydrochloride) Cream, 2%.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies to evaluate the carcinogenic potential of NAFTIN (naftifine hydrochloride) Cream, 2% have not been performed.
Pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies of NAFTIN (naftifine hydrochloride) Cream, 2% in pregnant women. Because animal reproduction studies are not always predictive of human response, NAFTIN (naftifine hydrochloride) Cream, 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NAFTIN (naftifine hydrochloride) Cream, 2% is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established. The number of pediatric patients ≤12 years of age studied was too small to adequately assess safety and efficacy.
ADVERSE REACTIONS: In clinical trials with NAFTIN (naftifine hydrochloride) Cream, 2% the most common adverse reaction (≥1%) was pruritus.
Brief Summary of Full Prescribing Information for Naftin Gel, 2%
INDICATIONS AND USAGE: NAFTIN (naftifine hydrochloride) Gel, 2% is an allylamine antifungal indicated for the treatment of interdigital tinea pedis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.
CONTRAINDICATIONS: None.
WARNINGS AND PRECAUTIONS: If redness or irritation develops with the use of NAFTIN Gel, 2% treatment should be discontinued.
Information for Patients:
1. Inform patients that NAFTIN (naftifine hydrochloride) Gel, 2% is for topical use only. NAFTIN (naftifine hydrochloride) Gel, 2% is not intended for ophthalmic, oral, or intravaginal use.
2. Patients should be directed to contact their physician if irritation develops with the use of NAFTIN (naftifine hydrochloride) Gel, 2%.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies to evaluate the carcinogenic potential of NAFTIN (naftifine hydrochloride) Gel, 2% have not been performed.
Pregnancy: Pregnancy Category B. There are no adequate and well-controlled trials of NAFTIN (naftifine hydrochloride) Gel, 2% in pregnant women. Because animal reproduction studies are not always predictive of human response, NAFTIN (naftifine hydrochloride) Gel, 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when NAFTIN (naftifine hydrochloride) Gel, 2% is administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established. The number of pediatric subjects ≤12 years of age studied was too small to adequately assess safety and efficacy.
ADVERSE REACTIONS: In clinical trials with NAFTIN (naftifine hydrochloride) Gel, 2%, the most common adverse reactions (2%) were application site reactions.
Please see Full Prescribing Information, including Medication Guide for more information.
1 Symphony Health Solutions – PHAST Data, October 2014
