Topical regional neuro-affective therapy

Abstract

A method of treating a disease state or condition in humans via topical brainstem afferent stimulation therapy via the administration of a drug to the back of the neck of a human patient at the hairline in close proximity to and under or on the area of skin above the brain stem to provide regional neuro-affective therapy is disclosed.

1 . A method of treating ADD/ADHD in a human patient, comprising administering a drug for the treatment of ADD/ADHD in a therapeutically effective amount to treat the disease state or condition, to the back of the neck at the hairline in close proximity to and under or on the area of skin above the brain stem to provide regional neuro-affective therapy to the human patient. 
     
     
         2 . The method of  claim 1 , wherein the drug is an amphetamine derivative. 
     
     
         3 . (canceled) 
     
     
         4 . The method of  claim 2 , wherein the drug is selected from the group consisting of lisdexamfetamine, d-amphetamine, l-amphetamine, methylphenidate, dextroamphetamine, dexmethylphenidate hydrochloride, atomoxetine, phentermine, fenfluramine, dexfenfluramine and mixtures thereof. 
     
     
         5 . The method of  claim 2 , diseases wherein the drug comprises phentermine. 
     
     
         6 . The method of  claim 1 , wherein the drug is selected from the group consisting of lisdexamfetamine, d-amphetamine, l-amphetamine, methylphenidate, dextroamphetamine, dexmethylphenidate hydrochloride, atomoxetine, and mixtures of any of the foregoing. 
     
     
         7 . The method of  claim 2 , wherein the drug consists of phentermine. 
     
     
         8 - 24 . (canceled) 
     
     
         25 . The method of  claim 1 , wherein the drug is formulated in a pharmaceutically acceptable immediate release topical carrier. 
     
     
         26 . The method of  claim 25 , wherein the carrier is aqueous-based. 
     
     
         27 . The method of  claim 1 , further comprising formulating the drug for the treatment of ADD/ADHD in a pharmaceutically acceptable immediate release aqueous-based carrier, and applying a sufficient amount to the back of the neck at the hairline (“BONATH”) of the human patient such that the onset of clinical effect occurs in less than about 30 minutes. 
     
     
         28 . (canceled) 
     
     
         29 . The method of  claim 25 , wherein the carrier is a gel or cream. 
     
     
         30 . The method of  claim 29 , further comprising adding at least one adjuvant selected from the group consisting of a penetration enhancer, antioxidant, stabilizer, and mixtures thereof to the carrier. 
     
     
         31 . The method of  claim 1 , wherein the drug for the treatment of ADD/ADHD is incorporated into a sustained release transdermal delivery system which is capable of delivering the drug through the skin of a human patient over a 24 hour period, the transdermal delivery system being capable of delivering the drug in such amounts for a time period from about 1 to about 7 days. 
     
     
         32 . The method of  claim 31 , wherein the transdermal delivery system is selected from the group consisting of a transdermal patch, a transdermal plaster, a transdermal disc, and an iontophoretic transdermal device. 
     
     
         33 . The method of  claim 1 , further comprising formulating the drug in a pharmaceutically acceptable immediate release aqueous-based carrier, and applying a sufficient amount to the BONATH of the human patient such that the onset of clinical effect occurs in less than about 15 minutes. 
     
     
         34 . The method of  claim 1 , wherein the drug is administered via implantation or injection at the BONATH. 
     
     
         35 . The method of  claim 1 , wherein the drug is administered via injection in an immediate release pharmaceutically acceptable carrier for injection. 
     
     
         36 . The method of  claim 1 , wherein the drug is administered via injection or implantation in a controlled release carrier to provide a prolonged effect of the drug. 
     
     
         37 . The method of  claim 1 , wherein the drug is incorporated into a delivery system selected from the group consisting of a gel, a matrix, microparticles, a pellet, an insert, a colloidal material, and mixtures of any of the foregoing. 
     
     
         38 . The method of  claim 1 , wherein the drug is administered to create a depot under the skin at the BONATH. 
     
     
         39 . (canceled) 
     
     
         40 . The method of  claim 1 , wherein the administration provides an effective administration of drug at the back of the neck at the hairline in close proximity to and under or on the area of skin above the brain stem to provide a therapeutic effect for at least about 3 days. 
     
     
         41 - 51 . (canceled)