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Claims for Patent: 8,765,680

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Claims for Patent: 8,765,680

Title: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 .omega.-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.
Inventor(s): Ellis; David J. (Los Altos, CA), Miljanich; George P. (Redwood City, CA), Shields; David E. (San Lorenzo, CA)
Assignee: Jazz Pharmaceuticals International Limited (Hamilton, BM)
Application Number:14/133,303
Patent Claims: 1. A method for treating severe chronic pain in a human patient, comprising: (a) administering to a human patient suffering from severe chronic pain who has an implantable pump a therapeutically effective amount of an .omega.-conopeptide by continuous intrathecal infusion using the pump, and (b) administering to the human patient a therapeutically effective amount of an opioid without admixing the .omega.-conopeptide and the opioid in the pump, wherein the opioid is morphine or hydromorphone.

2. The method of claim 1, wherein the opioid is morphine.

3. The method of claim 1, wherein the .omega.-conopeptide is ziconotide.

4. The method according to claim 3, wherein said ziconotide is administered in a pharmaceutical composition comprising an antioxidant.

5. The method according to claim 4, wherein said antioxidant is methionine.

6. The method according to claim 4, wherein said pharmaceutical formulation has pH between 4 and 4.5.

7. A method for treating severe chronic pain in a human patient, comprising: (a) administering to a human patient suffering from severe chronic pain who has an implantable pump a therapeutically effective amount of an .omega.-conopeptide by continuous intrathecal infusion using the pump, and (b) administering to the human patient a therapeutically effective amount of an opioid, wherein the opioid is morphine or hydromorphone, and (c) recommending against admixing the .omega.-conopeptide with the opioid for a period longer than a week.

8. The method according to claim 7, wherein the period is longer than 14 days.

9. The method according to claim 8, wherein the opioid is hydromorphone.

10. The method according to claim 8, wherein the opioid is morphine.

11. The method of claim 8, wherein the .omega.-conopeptide is ziconotide.

12. The method according to claim 11, wherein said ziconotide is administered in a pharmaceutical composition comprising an antioxidant.

13. The method according to claim 12, wherein said antioxidant is methionine.

14. The method according to claim 12, wherein said pharmaceutical formulation has pH between 4 and 4.5.

15. A method for treating severe chronic pain in a human patient, comprising the steps of: (a) selecting a human patient suffering from severe chronic pain who is being administered a therapeutically effective amount of an .omega.-conopeptide by continuous intrathecal infusion with an implantable pump, the human patient is also being administered a therapeutically effective amount of an opioid, wherein the opioid is morphine or hydromorphone, and (b) recommending against admixing the .omega.-conopeptide and the opioid in the pump.

16. The method of claim 15, wherein the opioid is morphine.

17. The method of claim 15, wherein the .omega.-conopeptide is ziconotide.

18. A method for treating severe chronic pain in a human patient that is suffering from severe chronic pain and who has an implantable pump which administers a therapeutically effective amount of an .omega.-conopeptide by continuous intrathecal infusion, the method comprises the step of: administering to the human patient a therapeutically effective amount of an opioid, recommending against admixing the .omega.-conopeptide and the opioid in the pump, wherein the opioid is morphine or hydromorphone.

19. The method of claim 18, wherein the opioid is morphine.

20. The method of claim 18, wherein the .omega.-conopeptide is ziconotide.

21. The method of claim 18, wherein the opioid is orally or parenterally administered to the human patient.

22. The method of claim 18, wherein the .omega.-conopeptide is formulated with an anti-oxidant in a pharmaceutical composition.

23. The method of claim 18, wherein the .omega.-conopeptide is administered after the onset of pain.

24. The method of claim 18, wherein the .omega.-conopeptide is administered before an event known to elicit a severe chronic pain.
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