Use of ibogaine and derivatives thereof for the treatment of pain

Abstract

This invention is directed to methods of treating pain in patients comprising treating patients with ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof at a therapeutic dosage that provides an average serum concentration of about 50 ng/mL to about 850 ng/mL.

What is claimed is: 
     
         1 . A method for treating pain in a patient, comprising administering to the patient a dosage of ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof that provides an average serum concentration of about 50 ng/mL to about 500 ng/mL, said concentration being sufficient to alleviate and/or inhibit said pain while maintaining a QT interval of less than about 500 ms during said treatment. 
     
     
         2 . The method of  claim 1 , wherein the ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof is administered as a single dose or multiple doses. 
     
     
         3 . The method of  claim 1 , wherein the aggregate dosage of ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof is selected from the group consisting of from about 1.3 mg/kg to about 4 mg/kg per day, about 1.5 mg/kg to about 3 mg/kg per day, about 2 mg/kg to about 4 mg/kg per day, from about 2 mg/kg to about 3 mg/kg per day, and about 2 mg/kg per day. 
     
     
         4 . The method of  claim 1 , wherein the dosage of ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof provides an average serum concentration of about 50 ng/mL to about 200 ng/mL. 
     
     
         5 . A method for alleviating pain symptoms in a human patient susceptible to such symptoms, comprising administering to the patient a dosage of ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof that provides an average serum concentration of about 50 ng/mL to about 400 ng/mL, said concentration being sufficient to alleviate said pain symptoms while maintaining a QT interval of less than about 500 ms during said treatment. 
     
     
         6 . The method of  claim 5 , wherein the pain symptoms are due to chronic pain. 
     
     
         7 . The method of  claim 5 , wherein the ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof is administered as a single dose or multiple doses. 
     
     
         8 . The method of  claim 5 , wherein the aggregate dosage of ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof is selected from the group consisting of from about 1.3 mg/kg to about 4 mg/kg per day, about 1.5 mg/kg to about 3 mg/kg per day, about 2 mg/kg to about 4 mg/kg per day, about 2 mg/kg to about 3 mg/kg per day, and about 2 mg/kg per day. 
     
     
         9 . A pharmaceutically acceptable formulation comprising a unit dose of ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof wherein the amount of ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof is sufficient to provide a serum concentration of about 50 ng/mL to about 500 ng/mL when administered to a patient. 
     
     
         10 . The formulation of  claim 9 , wherein the unit dose of ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof is administered in one or more dosings. 
     
     
         11 . The method of  claim 1 , wherein the ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof is selected from the group consisting of coronaridine, ibogamine, voacangine, 18-methoxycoronaridine, 2-Methoxyethyl-18-methoxycoronaridinate, and 18-Methylaminocoronaridine. 
     
     
         12 . The method of  claim 1 , wherein the ibogaine, an ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof is selected from the group consisting of 16-hydroxymethyl-18-hydroxyibogaline, 16-hydroxymethyl-18-methoxyibogaline, 16-ethoxycarbonyl-18-hydroxyibogaline laurate, and 16-ethoxycarbonyl-18-hydroxyibogaline methoxyethoxymethyl ether.