Naftifine Hydrochloride (Page 3 of 3)

14.2 Interdigital Tinea Pedis

Naftifine hydrochloride cream has been investigated for efficacy in a randomized, double-blind, vehicle-controlled, multi-center trial in 217 subjects with symptomatic and dermatophyte culture positive interdigital tinea pedis. Subjects were randomized to receive naftifine hydrochloride cream or vehicle. Subjects applied naftifine hydrochloride cream or vehicle to the affected area of the foot plus a ½-inch margin of healthy skin surrounding the affected area once-daily for 2 weeks. Signs and symptoms of interdigital tinea pedis (presence or absence of erythema, pruritus, and scaling) were assessed and KOH examination and dermatophyte culture was performed at the primary efficacy endpoint at week 6.

The mean age of the trial population was 42 years and 71% were male and 57% were white. At baseline, subjects were confirmed to have signs and symptoms of interdigital tinea pedis, positive KOH exam, and confirmed dermatophyte culture. The primary efficacy endpoint was the proportions of subjects with a complete cure at the week 6 visit (see Table 2). Complete cure was defined as both a clinical cure (absence of erythema, pruritus, and scaling) and mycological cure (negative KOH and dermatophyte culture).

The efficacy results at week 6, four weeks following the end of treatment, are presented in Table 2 below. Naftifine hydrochloride cream demonstrated complete cure in subjects with interdigital tinea pedis, but complete cure in subjects with only moccasin type tinea pedis was not demonstrated.

Table 2 Efficacy Results for Pivotal Interdigital Tinea Pedis Trial (Week 6 Assessment)

Endpoint	Naftifine hydrochloride Cream, 2%	Vehicle
	N=147	N=70
Complete Curea	26 (18%)	5 (7%)
Effective Treatmentb	83 (57%)	14 (20%)
Mycological Curec	99 (67%)	15 (21%)
a. Complete cure is a composite endpoint of both mycological cure and clinical cure. Clinical cure is defined as absence of erythema, pruritus, and scaling (grade of 0).
b. Effective treatment is a negative KOH preparation and negative dermatophyte culture, erythema, scaling, and pruritus grades of 0 or 1 (absent or near absent).
c. Mycological cure is defined as negative KOH and dermatophyte culture.

14.3 Tinea corporis

Naftifine hydrochloride cream has been investigated for safety and efficacy in a randomized, double-blind, vehicle-controlled, multi-center trial in 184 subjects with symptomatic and dermatophyte culture positive tinea corporis. Subjects were randomized to receive naftifine hydrochloride cream or vehicle. Subjects applied the study agent to all affected body surface areas with tinea corporis plus a ½ inch margin of healthy skin surrounding the affected lesions for two weeks. Signs and symptoms of tinea corporis (presence or absence of erythema, induration, and pruritus) were assessed and KOH examination and dermatophyte culture were performed for the assessment of primary efficacy endpoint at Day 21.

The trial population was pediatric (greater than or equal to 2 to less than 18 years of age) with a median age of 9 years (naftifine hydrochloride cream) or 8 years (vehicle); 61% of subjects were male and 45% were white. At baseline, subjects were confirmed to have signs and symptoms of tinea corporis, positive KOH exam, and confirmed dermatophyte culture. The primary efficacy endpoint was the proportions of subjects with a complete cure at the Day 21 visit. Complete cure was defined as both a clinical cure (absence of erythema, induration, and pruritus on all lesions present at baseline) and mycological cure (negative KOH and dermatophyte culture).

The efficacy results at Day 21, one week following the end of treatment, are presented in Table 3 below.

Table 3 Efficacy Results for Pediatric Tinea Corporis Trial (Day 21 Assessment)

	Naftifine Hydrochloride Cream, 2%	Vehicle
Endpoint	N=91	N=93
Complete Curea	42 (46%)	26 (28%)
Effective Treatmentb	53 (58%)	32 (34%)
Mycological Curec	57 (63%)	36 (39%)
a. Complete cure is a composite endpoint of both mycological cure and clinical cure. Clinical cure is defined as absence of erythema, pruritus, and scaling (grade of 0).
b. Effective treatment is a negative KOH preparation and negative dermatophyte culture, erythema, induration, and pruritus grades of 0 or 1 (absent or mild).
c. Mycological cure is defined as negative KOH and dermatophyte culture.

16 HOW SUPPLIED/STORAGE AND HANDLING

Naftifine hydrochloride cream, USP 2%, is a white to off-white cream supplied in the following size:

45 gram tubes – NDC 70700-161-18

60 gram tubes – NDC 70700-161-17

Store naftifine hydrochloride cream at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

• Inform patients that naftifine hydrochloride cream is for topical use only. Naftifine hydrochloride cream is not intended for oral, intravaginal or ophthalmic use.
• If irritation or sensitivity develops with the use of naftifine hydrochloride cream treatment should be discontinued and appropriate therapy instituted. Patients should be directed to contact their physician if these conditions develop following use of naftifine hydrochloride cream.

Distributed by:

Xiromed, LLC,

Florham Park, NJ 07932

Rev. 09/2020

PI-161-00

573063-01

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION — 45g Tube

NDC 70700-161-18
Naftifine Cream, 2%

Xiromed, LLC

For Topical Use Only
Not for Ophthalmic Use, Oral or Intravaginal Use

45 g

Rx Only

PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION — 60g Tube

NDC 70700-161-17
Naftifine Cream, 2%

Xiromed, LLC

For Topical Use Only
Not for Ophthalmic Use, Oral or Intravaginal Use

60 g

Rx Only

NAFTIFINE HYDROCHLORIDE naftifine hydrochloride cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-161 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NAFTIFINE HYDROCHLORIDE (NAFTIFINE) NAFTIFINE HYDROCHLORIDE 20 mg in 1 g

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL CETYL ALCOHOL CETYL ESTERS WAX ISOPROPYL MYRISTATE POLYSORBATE 60 WATER SODIUM HYDROXIDE SORBITAN MONOSTEARATE STEARYL ALCOHOL HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70700-161-18 1 TUBE in 1 CARTON contains a TUBE 1 45 g in 1 TUBE This package is contained within the CARTON (70700-161-18) 2 NDC:70700-161-17 1 TUBE in 1 CARTON contains a TUBE 2 60 g in 1 TUBE This package is contained within the CARTON (70700-161-17)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210038 01/15/2021

Labeler — Xiromed, LLC (080228637)

Registrant — Xiromed Pharma España, S.L. (468835741)

Revised: 01/2021 Xiromed, LLC