Methods of using a phenoxypropylamine compound to treat pain

Abstract

The present disclosure relates to methods of treating pain, fibromyalgia, neuropathy, chemotherapy-induced pain, promoting an antihyperalgesic effect, and reducing sensitivity to pain, in a subject in need of such treatment comprising the administration of a therapeutically effective amount of Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof.

1 . A method of treating or preventing pain in a subject in need of treatment comprising administering to the subject a therapeutically effective amount of Compound I, 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt, solvate, or prodrug thereof. 
     
     
         2 . The method of  claim 1 , wherein the pain is acute pain, chronic pain, toxic pain, neuropathic pain, nociceptive pain, inflammatory pain, post-operative pain, visceral pain, chemotherapy-induced pain, or a combination thereof. 
     
     
         3 . The method of  claim 1 , wherein the pain is peripheral neuropathy. 
     
     
         4 . The method of  claim 3 , wherein the peripheral neuropathy is peripheral mononeuropathy. 
     
     
         5 . The method of  claim 3 , wherein the peripheral neuropathy is peripheral polyneuropathy. 
     
     
         6 . The method of  claim 1 , wherein the pain is chemotherapy-induced peripheral neuropathy. 
     
     
         7 . The method of  claim 6 , wherein the chemotherapy is paclitaxel. 
     
     
         8 . A method of treating or preventing fibromyalgia in a subject in need of treatment comprising administering to the subject a therapeutically effective amount of Compound I, 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt, solvate, or prodrug thereof. 
     
     
         9 . A method of treating or preventing neuropathy in a subject in need of treatment comprising administering to the subject a therapeutically effective amount of Compound I, 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt, solvate, or prodrug thereof. 
     
     
         10 . The method of  claim 9 , wherein the neuropathy is peripheral neuropathy. 
     
     
         11 . The method of  claim 9 , wherein the neuropathy is peripheral mononeuropathy. 
     
     
         12 . The method of  claim 9 , wherein the neuropathy is peripheral polyneuropathy. 
     
     
         13 . The method of  claim 9 , wherein the neuropathy is induced by chemotherapy. 
     
     
         14 . A method of treating or preventing chemotherapy-induced pain in a subject in need of treatment comprising administering to the subject a therapeutically effective amount of Compound 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt, solvate, or prodrug thereof. 
     
     
         15 . The method of  claim 14 , wherein the chemotherapy-induced pain is peripheral neuropathic pain. 
     
     
         16 . The method of  claim 14  or  15 , wherein the chemotherapy is paclitaxel. 
     
     
         17 . A method of promoting an antihyperalgesic effect in a subject suffering from hyperalgesia comprising administering to the subject a therapeutically effective amount of Compound I, 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt, solvate, or prodrug thereof. 
     
     
         18 . A method of reducing sensitivity to pain in a subject, comprising administering to the subject a therapeutically effective amount of Compound I, 
       
         
           
           
               
               
           
         
       
       or a pharmaceutically acceptable salt, solvate, or prodrug thereof. 
     
     
         19 . The method of any one of the previous claims, wherein the therapeutically effective amount of Compound I is 0.1 mg/kg to 100 mg/kg. 
     
     
         20 . The method of any one of the previous claims, wherein the therapeutically effective amount of Compound I is about 10 mg/kg. 
     
     
         21 . The method of any one of  claims 1 - 18 , wherein the therapeutically effective amount of Compound I is 1 mg to 1,000 mg. 
     
     
         22 . The method of any one of the previous claims, wherein the therapeutically effective amount of Compound I is administered to the subject once a day, twice a day, three times a day, four times a day, once every two days, once every three days, once every four days, once every five days, once every six days, once a week, once every two weeks, once every three weeks, or once a month. 
     
     
         23 . The method of any one of the previous claims, wherein Compound I is formulated as a pharmaceutical composition comprising one or more pharmaceutically acceptable excipients. 
     
     
         24 . The method of  claim 23 , wherein the pharmaceutical composition further comprises an additional therapeutic agent for the treatment of pain. 
     
     
         25 . The method of any one of the previous claims, wherein Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, or the pharmaceutical composition comprising Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, is administered orally, parenterally, intravenously, intramuscularly, intrathecally, subcutaneously, topically, systemically, cutaneously, sublingually, buccally, rectally, vaginally, ocularly, otically, nasally, by inhalation, by nebulization, or transdermally. 
     
     
         26 . The method of any one of the previous claims, wherein Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, or the pharmaceutical composition comprising Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, is administered to the subject orally and is formulated as a tablet, capsule, chew, gel, paste, multi-particulate, nanoparticulate, lozenge, pastille, granule, powder, solution, spray, emulsion, suspension, syrup, mouthwash, or drop. 
     
     
         27 . The method of any one of the previous claims, wherein Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, or a pharmaceutical composition comprising Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, is administered to the subject topically and is formulated as a cream, paste, lotion, gel, patch, or spray. 
     
     
         28 . The method of any one of the previous claims further comprising administering an additional therapeutic agent for the treatment of pain. 
     
     
         29 . The method of  claim 28 , wherein the additional therapeutic agent for the treatment of pain and Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, or a pharmaceutical composition comprising Compound I, or a pharmaceutically acceptable salt, solvate, or prodrug thereof, are administered in temporal proximity. 
     
     
         30 . The method of any one of the previous claims, wherein the subject is a human. 
     
     
         31 . The method of any one of the previous claims, wherein upon improvement in the subject's pain, fibromyalgia, neuropathy, or chemotherapy-induced pain, upon promotion of an antihyperalgesic effect in the subject, or upon a reduction in the subject's sensitivity to pain, the subject is then administered a maintenance dose of Compound I and/or an additional therapeutic agent for the treatment of pain. 
     
     
         32 . The method of  claim 31 , wherein the maintenance dose of Compound I and/or the additional therapeutic agent is lower than the induction dose, administered less frequently than the induction dose, or lower than the induction dose and administered less frequently than the induction dose. 
     
     
         33 . The method of any one of the previous claims, wherein Compound I is a hydrochloride salt.