IP Library › Granted Patent US 11,771,661
Granted Patent B2
US 11,771,661 · App. 16/674,381 · Granted Oct 3, 2023

Method of treating post-traumatic stress disorder

Inventors: Dennis S. Charney (Chappaqua, NY); Adriana Feder (New York, NY)
Assignee: Icahn School of Medicine at Mount Sinai
A61K31/135A61K9/0019A61K9/0043A61K31/428A61K31/445A61K31/4525A61K31/517A61K31/53A61K33/00A61K45/06
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Quick Facts
Patent No.
US 11,771,661
App. No.
16/674,381
Filed
Nov 5, 2019
Granted
Oct 3, 2023
Kind
B2
Art Unit
1642
USPC
514/242
Abstract

The present disclosure provides compositions containing ketamine and methods of using those compositions for the treatment of post-traumatic stress disorder. Also provided herein is a pharmaceutical composition that comprises esketamine and a pharmaceutically acceptable carrier, excipient or diluent, for use in treatment of PTSD. In some aspects, the pharmaceutical composition is for intranasal or intravenous administration. In some aspects, the pharmaceutical composition is for use in a method of treating PTSD in a subject. In some aspects, the pharmaceutical composition is for use in a method of treating major depressive disorder in a subject that is co-morbid with the PTSD.

Claims (25)

1. A method of treating post-traumatic stress disorder (PTSD) in a patient determined to be suffering from PTSD, comprising conducting a psychiatric evaluation of a patient to determine if the patient is afflicted with PTSD, and intranasally administering to the patient, if the patient is determined to be suffering from PTSD multiple sub-analgesic therapeutic doses of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof of between about 0.01 to about 3.0 mg of per kilogram of body weight of the patient (mg/kg) being treated.

2. The method of claim 1 , wherein each dose of the multiple sub-analgesic therapeutic doses of ((2-(2-chlorophenyl)-2-(methylamino) -cyclohexanone) or a pharmaceutically acceptable salt thereof is a dose of about 0.01 to about 2.0 mg of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) per kilogram of body weight of the patient (mg/kg) to treat the PTSD.

3. The method of claim 2 , wherein each dose is about 0.05 to about 0.5 mg/kg of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone).

4. The method of claim 2 , wherein each dose is less than about 0.5 mg/kg, less than about 0.4 mg/kg or less than about 0.3 mg/kg of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone).

5. The method of claim 1 , wherein the patient is treated intranasally with ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone), substantially only via the nasal respiratory epithelium.

6. The method of claim 1 , wherein the patient is treated intranasally with ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone), substantially only via the nasal olfactory epithelium.

7. The method of claims 1 , wherein the patient is treated with a single dose of the therapeutically effective amount of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone).

8. The method of claim 1 wherein the patient is treated with at least one dose of the therapeutically effective amount of ((2-(2-chlorophenyl)-2 -(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof per week for a period of two or more weeks.

9. The method of claims 1 , further comprising administering a second agent to treat the PTSD.

10. The method of claim 9 , wherein the second agent is an anti-depressant.

11. The method of claim 9 , wherein the second agent is a member selected from the group consisting of paroxetine, sertraline, lithium, riluzole, prazosin, lamotrigine, or ifenprodil.

12. The method of claim 11 , wherein the second agent is used as adjunctive therapy to ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) treatment.

13. The method of claims 9 , wherein the treatment comprises a phase wherein treatment with the second agent takes place after treatment with ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) has ceased.

14. The method of any one of claims 9 - 13 , wherein the treatment comprises a phase where treatment with ((2-(2-chlorophenyl)-2-(methylamino) -cyclohexanone) or a pharmaceutically acceptable salt thereof and treatment with the second agent overlap.

15. The method of claim 1 wherein the ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof is administered in a composition comprising a pharmaceutically acceptable carrier, excipient or diluent.

16. The method of any one of claims 1 - 3 , wherein the ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof is esketamine.

17. The method of any one of claims 1 - 3 , wherein the total dose of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof is about 25 mg.

18. The method of any one of claims 1 - 3 , wherein the total dose of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof ketamine is about 50 mg.

19. The method of claims 1 - 3 , wherein the total dose of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof is about 75 mg.

20. The method of any one of claims 1 - 3 , wherein the total dose of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof is about 100 mg.

21. The method of any one of claims 1 - 3 , wherein the total dose of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof is about 1.1 mg/kg.

22. The method of claim 1 which comprises determining if the patient determined to be suffering from PTSD has responded to the first dose of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof and administering to the patient a second dose of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof ketamine if the patient has responded to the first dose of ((2-(2-chlorophenyl)-2-(methylamino) -cyclohexanone) wherein the second dose is lower than the first dose.

23. The method of claim 1 which comprises determining if the patient determined to be suffering from PTSD has responded to the first dose of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof and administering to the patient a second dose of ((2-(2-chlorophenyl)-2-(methylamino) cyclohexanone) or a pharmaceutically acceptable salt thereof , wherein the second dose is higher than the first dose.

24. The method of claim 1 wherein the intranasal administration comprises administering the ((2-(2-chlorophenyl)-2-(methylamino)-cyclohexanone) or a pharmaceutically acceptable salt thereof to the olfactory epithelium at the roof of the nasal cavity.

25. The method of claim 1 wherein the administering step bypasses the blood brain barrier.

Continuity (5)
Continuation 14974576 · Dec 18, 2015
Continuation 14783686
Provisional Application 61915947 · Dec 13, 2013
Provisional Application 61811681 · Apr 12, 2013
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