Anti-infective methods, compositions, and devices

Abstract

The present invention provides methods for treating onychomycosis. In certain embodiments, the methods comprise comprising applying a pharmaceutically acceptable formulation containing 10% efinaconazole once a day for a treatment period of at least 36 weeks to the treatment area of an onychomycosis patient (a) without debriding the nail or nail-associated tissue initially or during the treatment period and/or (b) without removing the formulation from the treatment area during the treatment period. In certain embodiments, the formulation also comprises, water, cyclomethicone, diisopropyl adipate, alcohol, C12-15 alkyl lactate, butylated hydroxytoluene, citric acid anhydrous, and disodium edetate.

What is claimed is: 
     
         1 . A method for treating onychomycosis comprising:
 (a) providing a container that is suitable for storing an efinaconazole formulation for pharmaceutical use that comprises an applicator that is capable of dispensing a pharmaceutically effective dose of an efinaconazole solution and spreading an approximately uniform amount of the efinaconazole formulation to a target area by manual action after loading,   (b) loading the applicator with the dose of the efinaconazole formulation, wherein the formulation comprises 10% w/w efinaconazole, alcohol, cyclomethicone, diisopropyl adipate, either or both of C12-15 alkyl lactate and isopropyl myristate, an antioxidant, butylated hydroxytoluene (BHT), and a salt of disodium edetate ethylenediaminetetraacetic acid (EDTA), and   (c) administering the dose of the efinaconazole formulation to the treatment area of each treated toe by uniform manual spreading.   
     
     
         2 . The method of  claim 1 , wherein the container is a multiple use container and the method comprises repeating steps (a)-(c) of the method for each toe area in the treatment area once a day for at least 4 weeks. 
     
     
         3 . The method of  claim 1 , wherein the method comprises manually loading of the applicator with a dose of the efinaconazole formulation. 
     
     
         4 . The method of  claim 3 , wherein the container is a squeeze sensitive container and the applicator is a flow through applicator which delivers efinaconazole formulation to the target area when a user applies sufficient pressure on the container. 
     
     
         5 . The method of  claim 1 , wherein the method is performed for at least 36 weeks. 
     
     
         6 . The method of  claim 5 , wherein the method is performed for 48 weeks. 
     
     
         7 . The method of  claim 1 , wherein the applicator is selected from the group consisting of a brush, a pad, a swab, a sponge, or a roller. 
     
     
         8 . The method of  claim 1 , wherein the volume of formulation contained in the applicator is about 75 to about 150 microliters. 
     
     
         9 . The method of  claim 1 , wherein the method comprises cutting nails once every two weeks or more frequently. 
     
     
         10 . The method of  claim 1 , wherein the method does not comprise cutting nails more often than every two weeks. 
     
     
         11 . The method of  claim 1 , wherein the efinaconazole formulation is not administered in an occluded or semi-occluded manner. 
     
     
         12 . The method of  claim 1 , wherein the efinaconazole formulation is administered without debriding the nail or nail-associated tissue initially or during the treatment period. 
     
     
         13 . The method of  claim 1 , wherein the efinaconazole formulation is administered without removing the formulation from the treatment area during the treatment period. 
     
     
         14 . The method of  claim 1 , wherein the formulation further comprises water. 
     
     
         15 . The method of  claim 1 , wherein the average amount of efinaconazole delivered to each cm 2  of the treatment area is about 0.15 mg/cm 2  to about 0.45 mg/cm 2 . 
     
     
         16 . The method of  claim 1 , wherein performance of the method in a patient population results in a mycological cure rate of at least about 40%, a clinical efficacy rate of at least about 20%, a complete cure rate of at least about 10%, or a combination of any or all thereof