Method for administering omega-conopeptide

Abstract

The present invention is directed to a method of producing analgesia in a mammalian subject. The method includes administering to the subject an omega conopeptide, preferably ziconotide, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyl 1, buprenorphine, and sufentanil, or its pharmaceutically acceptable salts thereof, wherein the ω-conopeptide retains its potency and is physically and chemically compatible with the analgesic compound. A preferred route of administration is intrathecal administration, particularly continuous intrathecal infusion. The present invention is also directed to a pharmaceutical formulation comprising an omega conopeptide, preferably ziconotide, an antioxidant, in combination with an analgesic selected from the group consisting of morphine, bupivacaine, clonidine, hydromorphone, baclofen, fentanyl, buprenorphine, and sufentanil.

What is claimed is: 
     
         1 . A method of administering an ω-conopeptide to a patient in need thereof for severe chronic pain, comprising administering to the patient a therapeutically effective amount of an ω-conopeptide thereof while avoiding admixture with an opioid, wherein said patient is also in need of therapy with the opioid. 
     
     
         2 . The method of  claim 1 , wherein the opioid is morphine sulfate. 
     
     
         3 . The method of  claim 1 , wherein the ω-conopeptide is administered via a continuous infusion pump. 
     
     
         4 . The method of  claim 1 , wherein the ω-conopeptide is ziconotide. 
     
     
         5 . The method according to  claim 5 , wherein said ziconotide is administered in a pharmaceutical composition comprising an antioxidant. 
     
     
         6 . A method for treating severe chronic pain in a human patient, comprising:
 (a) administering to a human patient suffering from severe chronic pain a therapeutically effective amount of an ω-conopeptide by intrathecal infusion, and   (b) systemically administering to the human patient a therapeutically effective amount of an opioid.   
     
     
         7 . The method according to  claim 6 , wherein the opioid is morphine or hydromorphone. 
     
     
         8 . The method of  claim 7 , wherein the opioid is morphine. 
     
     
         9 . The method of  claim 6 , wherein the ω-conopeptide is ziconotide. 
     
     
         10 . The method according to  claim 9 , wherein said ziconotide is administered in a pharmaceutical composition comprising an antioxidant. 
     
     
         11 . The method according to  claim 10 , wherein said antioxidant is methionine. 
     
     
         12 . The method according to  claim 10 , wherein said pharmaceutical formulation has pH between 4 and 4.5. 
     
     
         13 . The method according to  claim 9 , wherein said ziconotide is supplied in a single dose vial. 
     
     
         14 . The method according to  claim 13 , wherein said ziconotide has a concentration of 100 μg/mL in the vial. 
     
     
         15 . The method of  claim 6 , wherein the opioid is orally administered to the human patient. 
     
     
         16 . The method of  claim 6 , wherein the opioid is parenterally administered to the human patient.