Therapy procedure for drug delivery for trigeminal pain

Abstract

The present invention relates to methods for the treatment or prevention of trigeminal nerve-associated pain, in particular chronic, acute and procedural-related pain. The methods comprise administration of analgesic agents to the trigeminal nerve system which results in analgesia to the facial or head region.

1 - 41 . (canceled) 
     
     
         42 . A method of treating head pain in an individual in need thereof comprising:
 intranasally administering an analgesic agent to the individual, wherein the analgesic agent is selected from the group consisting of an oxytocin peptide, an enkephalin, an endorphin, a dynorphin, a CGRP antagonist, a CGRP antibody, and an analogue of any of the foregoing, and wherein the administration of the analgesic agent results in reduction of head pain.   
     
     
         43 . The method of  claim 42  wherein the analgesic agent is administered to the inferior two-thirds of the nasal cavity. 
     
     
         44 . The method of  claim 42 , wherein the analgesic agent is administered as a pharmaceutical formulation. 
     
     
         45 . The method of  claim 44 , wherein the pharmaceutical formulation comprises at least one absorption enhancer. 
     
     
         46 . The method of  claim 42 , further comprising administering a second analgesic agent. 
     
     
         47 . The method of  claim 46 , wherein the second analgesic agent is administered intranasally. 
     
     
         48 . The method of  claim 42  further comprising administering a vasoconstrictor. 
     
     
         49 . The method of  claim 48 , wherein the vasoconstrictor is administered intranasally. 
     
     
         50 . The method of  claim 42 , wherein the head pain is the result of trigeminal neuralgia, atypical facial pain, cancer, infection, a burn, a laceration, a broken bone, a toothache, temporomandibular joint disorder (TMJ), a procedure, or a headache. 
     
     
         51 . The method of  claim 50 , wherein the head pain is the result of a headache. 
     
     
         52 . The method of  claim 51 , wherein the headache is a migraine headache. 
     
     
         53 . The method of  claim 42 , wherein the reduction of head pain occurs within ten minutes of administration. 
     
     
         54 . The method of  claim 42 , wherein the reduction of head pain occurs within twenty-five minutes of administration. 
     
     
         55 . The method of  claim 42 , wherein the reduction of head pain occurs within thirty minutes of administration. 
     
     
         56 . A kit for use in treating head pain comprising:
 a pharmaceutical formulation comprising an analgesic agent and a pharmaceutically acceptable carrier, the analgesic agent in an amount effective to reduce head pain, and wherein the analgesic is selected from the group consisting of an oxytocin, an enkephalin, an endorphin, a dynorphin, a CGRP antagonist, a CGRP antibody, and an analogue of any of the foregoing; and   a delivery device configured for intranasal delivery of the analgesic agent.   
     
     
         57 . The kit of  claim 56 , wherein the delivery device is configured to administer the pharmaceutical formulation to the inferior two-thirds of the nasal cavity. 
     
     
         58 . The kit of  claim 56 , wherein the delivery device is selected from the group consisting of a dose inhaler, a nebulizer, a nasal tampon, a pump spray, a dropper, a spray bottle, and an insufflator. 
     
     
         59 . The kit of  claim 56 , wherein the pharmaceutical formulation is preloaded in the delivery device. 
     
     
         60 . The kit of  claim 56 , wherein the pharmaceutical formulation is enclosed in a storage container. 
     
     
         61 . A method of treating non-migraine or non-cluster headache head pain in an individual in need thereof comprising:
 intranasally administering octreotide, calcitonin, or an analogue thereof to the individual, wherein the administration of the analgesic agent results in reduction of head pain, and wherein the head pain is not the result of a migraine or a cluster headache.   
     
     
         62 . The method of  claim 42 , wherein the reduction of head pain is at least 30% based on a VAS pain rating test. 
     
     
         63 . The method of  claim 42 , wherein the head pain is chronic head pain. 
     
     
         64 . The method of  claim 63 , wherein the chronic head pain is a result of TMJ.