Combination therapy for bipolar disorder

• US 8,138,169 B2
• Filed: 04/10/2009
• Issued: 03/20/2012
• Est. Priority Date: 04/11/2008
• Status: Active Grant

• Current Assignee: Comgenrx, Inc.
• Original Assignee: Comgenrx, Inc.
• Inventors: Oronsky, Bryan T., Oronsky, Neil C.
• Primary Examiner(s): Kim, Jennifer M
• Application Number:
  US12/422,156
• Publication Number:
  US 20090311347A1
• Time in Patent Office: 1,075 Days
• Field of Search: 514/211.13, 514/242, 514/254.04, 514/282
• US Class Current: 514/211.13
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/36 Opioid-abuse

Abstract

Treatment regimens for mood disorders that include administration of buprenorphine, alone or in combination with additional pharmacological agents are described. Specifically, treatment regimens that alleviate racing thoughts associated with bipolar disorder, and pharmaceutical compositions and kits for use therein are described. Dosing regimens, compositions, and kits including buprenorphine for treating mania associated with opioid withdrawal are also described.

Claims

1. A method for treating a manic episode in a subject suffering from a bipolar disorder or a subtype thereof, comprising administering buprenorphine or a pharmaceutically acceptable salt thereof to the subject to treat the manic episode.

2. The method of claim 1, wherein the bipolar disorder is bipolar I disorder.

3. The method of claim 1, wherein the bipolar disorder is bipolar II disorder.

4. The method of claim 1, wherein the bipolar disorder is mixed bipolar disorder.

5. The method of claim 4, wherein the subject affected with the mixed bipolar disorder rapidly cycles between manic or hypomanic phases and depressive phases.

6. The method of claim 5, wherein at least one episode of racing thoughts occurs during the depressive phase.

7. The method of claim 1, wherein the bipolar disorder subtype is cyclothymia.

8. The method of claim 1, wherein the bipolar disorder subtype is acute mania.

9. The method of claim 1, further comprising administering an opioid antagonist.

10. The method of claim 9, wherein the opioid antagonist comprises naloxone.

11. The method of claim 10, wherein buprenorphine and naloxone are administered together in a unit dose.

12. The method of claim 11, wherein about 2.0 mg of buprenorphine is administered in the unit dose.

13. The method of claim 11, wherein about 8.0 mg of buprenorphine is administered in the unit dose.

14. The method of claim 1, wherein about 2.0 mg of buprenorphine is administered to the subject.

15. The method of claim 1, wherein about 8.0 mg of buprenorphine is administered to the subject.

16. The method of claim 1, wherein a feature of the manic episode is that the subject experiences racing thoughts.