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Details for Patent: 8,268,774

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Details for Patent: 8,268,774

Title:Method for reducing pain
Abstract: The present invention is direct 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, fentanyil, 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: Azur Pharma International Limited (Hamilton, BM)
Filing Date:Jul 05, 2011
Application Number:13/176,568
Claims:1. A method for reducing pain in a patient, comprising: administering to a patient in need thereof a pharmaceutical formulation comprising an effective amount of ziconotide, anti-oxidant, and an effective amount of an analgesic compound selected from the group consisting of hydromorphone, fentanyl, sufentanil, bupivicaine, clonidine, and buprenophine, or its pharmaceutically acceptable salts thereof, wherein said administering is continuous intrathecal infusion by a drug dispensing implantable pump, and the ziconotide retains its potency and is physically and chemically compatible with the analgesic compound, said pharmaceutical formulation retains at least 80% ziconotide activity at 37.degree. C. for at least 7 days.

2. The method according to claim 1, wherein said pharmaceutical formulation retains at least 80% ziconotide activity at 37.degree. C. for at least one month.

3. The method according to claim 1, wherein said analgesic compound is hydromorphone.

4. The method according to claim 1, wherein said analgesic compound is fentanyl.

5. The method according to claim 1, wherein said analgesic compound is sufentanil.

6. The method according to claim 1, wherein said analgesic compound is and buprenophine.

7. The method according to claim 1, wherein said antioxidant is methionine.

8. The method according to claim 1, wherein said pharmaceutical formulation has pH between 4 to 4.5.

9. A method for reducing pain in a patient, comprising: administering to a patient in need thereof a pharmaceutical formulation comprising an effective amount of an .omega.-conopeptide, anti-oxidant, and an effective amount of bupivicaine, or its pharmaceutically acceptable salts thereof, wherein said administering is continuous intrathecal infusion by a drug dispensing implantable pump, and the .omega.-conopeptide retains its potency and is physically and chemically compatible with the analgesic compound.

10. The method according to claim 9, wherein said .omega.-conopeptide is ziconotide.

11. The method according to claim 9, wherein said antioxidant is methionine.

12. The method according to claim 9, wherein said pharmaceutical formulation has pH between 4 to 4.5.
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