IP Library Granted Patent US 11,154,537
Granted Patent B2
US 11,154,537 · App. 16/101,217 · Granted Oct 26, 2021

Method of treatment for ketamine infusion

Inventors: John Bryan Clifton (San Antonio, TX); J Cannon Clifton (San Antonio, TX); Mark Alan Moran (San Antonio, TX); Scott Patrick Worrich (San Antonio, TX)
Assignee: Eleusis Therapeutics US, Inc.
A61K31/4178A61K9/0019A61K31/135A61K45/06A61P25/24A61K31/407A61K31/4045A61K31/5513A61K2300/00
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Quick Facts
Patent No.
US 11,154,537
App. No.
16/101,217
Granted
Oct 26, 2021
Kind
B2
Abstract

Methods for treatment for patients having depression and/or pain are contemplated as including an administration of first preparation comprising an antiemetic agent, preferably ondansetron, followed by a second preparation of a synergistic combination of ketamine and a benzodiazepine, preferably lorazepam, administered via a continuous intravenous infusion. Such methods may be seen to better alleviate depression and pain symptoms, and may result in reduced need for other medications.

Claims (38)

1. A method of treating a patient having depression in need of treatment, the method comprising:

administering to the patient a first preparation, the first preparation comprising a pharmacologically effective amount of an antiemetic agent; and

administering to the patient a second preparation, the second preparation being an intravenous infusion comprising a mixture of a pharmacologically effective amount of ketamine and a pharmacologically effective amount of a benzodiazepine.

2. The method of claim 1 , wherein the antiemetic agent of the first preparation comprises at least one compound selected from the group consisting of non-selective 5-HT antagonist, 5-HT 3 receptor antagonist, 5-HT 4 receptor agonist, CB 1 agonist, D 2 receptor antagonist, D 3 receptor antagonist, GABA receptor agonist, H 1 receptor antagonist, muscarinic acetylcholine receptor antagonist, NK 1 receptor antagonist, or combinations thereof.

3. The method of claim 2 , wherein the first preparation comprises an intravenous infusion of ondansetron.

4. The method of claim 1 , wherein in the second preparation, the benzodiazepine is selected from the group consisting of 1,4-benzodiazepine, 1,5-benzodiazepine, 2,3-benzodiazepine, triazolobenzodiazepine, imidazobenzodiazepine, oxazolobenzodiazepine, thienodiazepine, thienotriazolodiazepine, thienobenzodiazepine, pyridodiazepine, pyridotriazolodiazepine, pyrralodiazepine, tetrahydroisoquinobenzodiazepine, a benzodiazepine prodrug, or combinations thereof.

5. The method of claim 4 , wherein the benzodiazepine is lorazepam.

6. The method of claim 1 , wherein in the second preparation, the ratio of ketamine to benzodiazepine is between 100:1 and 10:1 by weight.

7. The method of claim 1 , wherein the second preparation is administered as a saline solution.

8. The method of claim 1 , wherein the second preparation additionally comprises a pharmacologically effective amount of one or more of: an anesthetic, a sedative, an antiemetic, an anticonvulsant, an antidepressant, an antimigraine, an antipsychotic, an anxiolytic, an antiparkinson.

9. The method of claim 8 , wherein the second preparation additionally comprises ondansetron.

10. The method of claim 1 , further comprising administering to the patient a third preparation, the third preparation comprising a pharmaceutically effective amount of an anti-inflammatory agent.

11. The method of claim 10 , wherein the third preparation comprises an intravenous infusion of ketorolac.

12. The method of claim 10 , wherein the third preparation comprises an intramuscular infusion of a pharmaceutically effective amount of a triptan.

13. The method of claim 12 , wherein the third preparation comprises sumatriptan.

14. The method of claim 1 , wherein the second preparation is administered via continuous intravenous infusion at a rate of between 20 and 150 mg of ketamine per hour.

15. The method of claim 1 , wherein the second preparation is administered via continuous intravenous infusion at a rate of between 40 and 100 mg of ketamine per hour.

16. The method of claim 14 , wherein the rate of administration of the second preparation is configured to vary during the period of administration.

17. The method of claim 16 , wherein the second preparation is initially delivered at a first rate of between 40-60 mg of ketamine per hour, subsequently delivered at a second rate of between 80-120 mg of ketamine per hour, and finally delivered at a third rate of about 20-40 mg of ketamine per hour.

18. The method of claim 1 , wherein during the administration of the second preparation, at least about 0.5 mg of ketamine is delivered to the patient per kg of the patient's body mass.

19. The method of claim 1 , wherein the administration of the second preparation is performed over a time period of at least an hour.

20. The method of claim 1 , wherein the patient has major depressive disorder.

21. The method of claim 1 , wherein

(i) the first preparation comprises an intravenous infusion of ondansetron;

(ii) in the second preparation the benzodiazepine is lorazepam; and

(iii) in the second preparation, the ratio of ketamine to benzodiazepine is between 100:1 and 10:1 by weight.

22. The method of claim 21 , wherein in the second preparation, the ratio of ketamine to benzodiazepine is 50:1 by weight.

23. The method of claim 22 , wherein the second preparation is administered via continuous intravenous infusion at a rate of between 40 and 100 mg of ketamine per hour.

24. The method of claim 23 , wherein the patient has major depressive disorder.

25. The method of claim 23 , wherein the first preparation comprises an intravenous infusion of 4 mg of ondansetron.

26. A method of treating depression in a patient in need thereof, the method comprising concurrently administering to the patient:

(i) a pharmacologically effective amount of an antiemetic agent;

(ii) a pharmacologically effective amount of ketamine; and

(iii) a pharmacologically effective amount of a benzodiazepine.

27. The method of claim 26 , wherein the administering is by intravenous infusion of a mixture of the antiemetic agent, the ketamine, and the benzodiazepine, wherein the ratio of ketamine to benzodiazepine is between 100:1 and 10:1 by weight.

28. The method of claim 27 , wherein the antiemetic agent is ondansetron and the benzodiazepine is lorazepam.

29. The method of claim 28 , wherein the intravenous infusion is administered at a rate of between 20 and 150 mg of ketamine per hour.

30. The method of claim 29 , wherein the patient has major depressive disorder.

Assignments (5)
SECURITY AGREEMENT Recorded Aug 9, 2022
From: ELEUSIS THERAPUTICS US, INC.
To: BECKLEY PSYTECH LIMITED
Reel/Frame 061119/0222 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 18, 2021
From: KALYPSO TC, LLC
To: ELEUSIS HOLDINGS LIMITED
Reel/Frame 056584/0582 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 18, 2021
From: ELEUSIS HOLDINGS LIMITED
To: ELEUSIS THERAPEUTICS US, INC.
Reel/Frame 056584/0736 →
CORRECTIVE ASSIGNMENT TO CORRECT THE RECEIVING PARTY CITY AND COUNTRY OF ADDRESS PREVIOUSLY RECORDED AT REEL: 046618 FRAME: 0521. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Recorded Aug 14, 2018
From: CLIFTON, JOHN BRYAN; CLIFTON, J CANNON; MORAN, MARK ALAN; WORRICH, SCOTT PATRICK
To: KALYPSO TC LLC
Reel/Frame 047306/0512 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 10, 2018
From: CLIFTON, JOHN BRYAN; CLIFTON, J CANNON; MORAN, MARK ALAN; WORRICH, SCOTT PATRICK
To: KALYPSO TC LLC
Reel/Frame 046618/0521 →
Continuity (1)
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