Methods and compositions for ibogaine treatment of impulse control disorder, anxiety-related disorders, violence and/or anger, or regulating food intake

• US 9,592,239 B2
• Filed: 03/02/2015
• Issued: 03/14/2017
• Est. Priority Date: 09/12/2014
• Status: Active Grant

• Current Assignee: DemeRx IB, Inc. (ATAI Life Sciences NV)
• Original Assignee: DemeRX, Inc.
• Inventors: Maillet, Emeline L.
• Primary Examiner(s): Murray, Jeffrey H
• Application Number:
  US14/635,905
• Publication Number:
  US 20160074414A1
• Time in Patent Office: 743 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole

Abstract

This invention provides a method for treating anxiety-related disorder or impulse control disorder, regulating food intake, attenuating food cravings, or treating anger and/or violence and disorders associated therewith in a patient, comprising administering to the patient in need thereof a therapeutically effective amount of ibogaine, ibogaine derivative, or a pharmaceutically acceptable salt and/or solvate thereof.

Claims

1. A method for treating an anxiety-related disorder in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a compound selected from ibogaine, an ibogaine derivative, and a pharmaceutically acceptable salt and/or solvate thereof, the ibogaine derivative selected from the group consisting of coronaridine, voacangine, 18-methoxycoronaridine, 2-methoxyethyl-18-methoxycoronaridinate, and 18-methylaminocoronaridine, wherein the patient is not addicted to cocaine or an opiate, and further wherein the therapeutically effective amount provides an efficacious average serum level of ibogaine or the ibogaine derivative of less than about 180 ng/mL while maintaining a QT interval of less than about 500 ms during said treatment.

2. The method of claim 1, wherein the anxiety-related disorder is selected from the group consisting of generalized anxiety disorder, panic disorder, obsessive-compulsive disorder, and social anxiety disorder.

3. The method of claim 1, comprising:

a) administering an initial dose of ibogaine, the ibogaine derivative, or the pharmaceutically acceptable salt or solvate thereof, wherein the initial dose provides an average serum concentration of less than about 180 ng/mL; and

b) administering at least one additional dose of ibogaine, the ibogaine derivative, or the pharmaceutically acceptable salt or solvate thereof, such that the at least one additional dose maintains the average serum concentration of less than about 180 ng/mL for a period of time.

4. The method of claim 3, wherein the initial dose is from about 75 mg to about 120 mg.

5. The method of claim 3, wherein the at least one additional dose is from about 5 mg to about 25 mg.

6. The method of claim 3, wherein the at least one additional dose is administered from about 6 hours to about 24 hours after the initial dose.

7. The method of claim 3, wherein at least two additional doses are administered, and further wherein the additional doses are administered from about 6 hours to about 24 hours after the previous dose.

8. The method of claim 1, wherein the QT interval is less than about 450 ms.

9. The method of claim 1, further comprising selecting a patient who is prescreened to evaluate tolerance for prolongation of QT interval.

10. The method of claim 1, wherein the ibogaine, ibogaine derivative, or the pharmaceutically acceptable salt or solvate thereof is administered by sublingual, buccal, intranasal, or intrapulmonary delivery.

11. The method of claim 1, wherein ibogaine or the pharmaceutically acceptable salt or solvate thereof is administered.

12. The method of claim 1, wherein the ibogaine derivative, or the pharmaceutically acceptable salt or solvate thereof is administered.

13. The method of claim 1, wherein the efficacious average serum level of ibogaine or the ibogaine derivative provided is less than about 50 ng/mL.

14. The method of claim 1, wherein the efficacious average serum level of ibogaine or the ibogaine derivative provided is between about 50 ng/mL and about 180 ng/mL.