CLINICAL TRIALS PROFILE FOR NAFTIN

All Clinical Trials for NAFTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02227290 ↗	Pediatric Subjects With Tinea Corporis	Completed	Merz North America, Inc.	Phase 4	2014-08-01	The study is being done to see how well the study cream works when applied once a day to affected area of child (where they have ringworm). The results will be compared to those seen with a placebo cream which has no active ingredient. Safety of the cream will also be measured.
NCT01885156 ↗	Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris	Completed	Merz North America, Inc.	Phase 3	2013-08-01	To see how well Naftin 1% cream works when applied once daily to the affected area. The results will be compared to those using a placebo cream, which is a cream with no active ingredient. Safety will also be measured.
NCT01885156 ↗	Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris	Completed	Merz Pharmaceuticals, LLC	Phase 3	2013-08-01	To see how well Naftin 1% cream works when applied once daily to the affected area. The results will be compared to those using a placebo cream, which is a cream with no active ingredient. Safety will also be measured.
NCT02132260 ↗	Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis	Completed	Taro Pharmaceuticals USA	Phase 1	2013-08-01	The objective of this study is to compare the efficacy and safety of the test formulation of Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week study in patients with tinea pedis.
NCT01580891 ↗	Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis	Completed	Taro Pharmaceuticals USA	Phase 1	2012-05-01	The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days.

Clinical Trial Conditions for NAFTIN

Condition Name

Condition Name for NAFTIN
Intervention	Trials
Tinea Pedis	5
Tinea Corporis	2
Tinea Cruris	2
Jock Itch	1

Condition MeSH

Condition MeSH for NAFTIN
Intervention	Trials
Tinea	8
Tinea Pedis	5
Tinea cruris	2

Clinical Trial Locations for NAFTIN

Trials by Country

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Trials by Country for NAFTIN
Location	Trials
United States	15
Dominican Republic	5
Honduras	3
Puerto Rico	1
Belize	1

Trials by US State

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Trials by US State for NAFTIN
Location	Trials
Texas	3
Missouri	2
Florida	2
California	2
Tennessee	1

Clinical Trial Progress for NAFTIN

Clinical Trial Phase

Clinical Trial Phase for NAFTIN
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 1	4

Clinical Trial Status

Clinical Trial Status for NAFTIN
Clinical Trial Phase	Trials
Completed	7
Recruiting	1

Clinical Trial Sponsors for NAFTIN

Sponsor Name

Sponsor Name for NAFTIN
Sponsor	Trials
Taro Pharmaceuticals USA	3
Merz North America, Inc.	3
Merz Pharmaceuticals, LLC	3

Sponsor Type

Sponsor Type for NAFTIN
Sponsor	Trials
Industry	12
Other	1

Naftin: Clinical Trials, Market Analysis, and Projections

Introduction to Naftin

Naftin, also known as naftifine hydrochloride, is a topical antifungal medication belonging to the allylamine group. It is widely used to treat various forms of dermatophytosis, including interdigital tinea pedis, tinea cruris, and other superficial fungal infections of the skin.

Clinical Trials Overview

Efficacy and Safety

Numerous clinical trials have been conducted to evaluate the efficacy and safety of Naftin. In two randomized, vehicle-controlled trials involving 400 patients, Naftin 2% cream demonstrated significant efficacy in treating tinea pedis and tinea cruris. The trials showed that most subjects received once-daily topical doses for 2 weeks, covering the affected skin areas plus a ½ inch margin of surrounding healthy skin. The results indicated a complete cure in a substantial number of subjects, defined by both clinical and mycological criteria, such as the absence of erythema, pruritus, and scaling, along with negative KOH and dermatophyte culture results[3][4].

Adverse Reactions

The clinical trials revealed that the incidence of adverse reactions in the Naftin-treated population was not significantly different from the vehicle-treated population. The most common adverse reaction was pruritus, and most adverse reactions were mild in severity[1][3].

Comparison with Other Antifungals

A phase III randomized controlled clinical trial compared the efficacy and safety of naftifine 2% cream with terbinafine 1% cream in patients with dermatophytosis. The study found that naftifine was effective and safe, with efficacy and safety profiles comparable to terbinafine. The composite cure rates were 94.07% for naftifine and 87.97% for terbinafine, with all adverse events being mild and resolving within four days[4].

Market Analysis

Market Value and Generic Launches

As of December 2021, Naftin cream and its generics had a market value of $4.1 million, according to IQVIA. Recently, Xiromed, in partnership with Genzum Life Sciences, launched a generic version of naftifine hydrochloride cream, 2%, which is expected to increase accessibility and affordability for patients. This move aligns with Xiromed's growth plan to deliver quality generics to the U.S. market[5].

Competitive Landscape

The launch of generic naftifine hydrochloride cream is set to impact the competitive landscape of topical antifungals. With multiple generic options available, patients and healthcare providers will have more choices, potentially driving market competition and influencing pricing strategies.

Market Projections

Drug Price Inflation

According to Vizient's summer 2024 Pharmacy Market Outlook, drug price inflation rates for pharmaceuticals, including antifungals like Naftin, are expected to be around 3.81% in 2025. This projection is based on purchase patterns and data from April 1, 2023, to March 31, 2024. The report highlights that factors such as increases in specialty and expensive medications, new drug approvals, expanded indications, and payer restrictions continue to drive inflation in the pharmaceutical space[2].

Growth Potential

Given the efficacy and safety profile of Naftin, along with the increasing demand for topical antifungals, the market for Naftin and its generics is expected to grow. The availability of generic options will likely increase market penetration, especially in regions where affordability is a significant factor.

Patient Access and Affordability

The introduction of generic naftifine hydrochloride cream is anticipated to improve patient access to this effective antifungal treatment. Generic medications are generally more affordable than their brand-name counterparts, which can lead to better adherence to treatment regimens and improved health outcomes.

Regulatory and Postmarketing Considerations

Pediatric and Geriatric Use

Clinical studies have shown that the safety and effectiveness of Naftin in pediatric patients under 12 years of age have not been established due to limited data. However, in geriatric patients, Naftin has demonstrated no adverse effects on growth, fertility, or reproduction at doses up to 100 mg/kg/day[3].

Nursing Mothers

It is not known whether naftifine hydrochloride is excreted in human milk, so caution is advised when administering Naftin to nursing women[3].

Key Takeaways

• Efficacy and Safety: Naftin has been proven effective and safe in treating dermatophytosis, with efficacy comparable to other topical antifungals like terbinafine.
• Market Value: The market value of Naftin and its generics was $4.1 million as of December 2021.
• Generic Launches: The launch of generic naftifine hydrochloride cream by Xiromed and Genzum is expected to increase accessibility and affordability.
• Market Projections: Drug price inflation is projected to be around 3.81% in 2025, driven by various factors including new drug approvals and expanded indications.
• Patient Access: Generic options are likely to improve patient access to effective antifungal treatments.

Frequently Asked Questions (FAQs)

1. What is Naftin used for?

Naftin, or naftifine hydrochloride, is used to treat various forms of dermatophytosis, including interdigital tinea pedis, tinea cruris, and other superficial fungal infections of the skin.

2. How effective is Naftin in clinical trials?

Naftin has demonstrated significant efficacy in clinical trials, with complete cure rates observed in a substantial number of subjects, defined by both clinical and mycological criteria.

3. What are the common adverse reactions associated with Naftin?

The most common adverse reaction associated with Naftin is pruritus, and most adverse reactions are mild in severity.

4. Are there generic versions of Naftin available?

Yes, generic versions of naftifine hydrochloride cream, 2%, have been launched by companies like Xiromed and Genzum Life Sciences.

5. What is the projected drug price inflation for 2025?

According to Vizient's summer 2024 Pharmacy Market Outlook, the drug price inflation rate for pharmaceuticals, including antifungals like Naftin, is expected to be around 3.81% in 2025.

Sources:

1. NAFTIN® NAFTIFINE HCl 1% Rx - FDA Label.
2. Vizient estimates a 3.81% inflation in drug prices in 2025 - TechTarget.
3. CENTER FOR DRUG EVALUATION AND RESEARCH - FDA NDA.
4. A phase III randomized controlled clinical trial evaluating the efficacy and safety of naftifine 2% cream versus terbinafine 1% cream in patients with superficial fungal infection of the skin - International Journal of Research in Dermatology.
5. Xiromed, Genzum unveil generic Naftin - Drug Store News.