IP Library Granted Patent US 10,980,803
Granted Patent B2
US 10,980,803 · App. 16/710,495 · Granted Apr 20, 2021

Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function

Inventor: Arash Raoufinia (Vienna, VA)
Assignee: Otsuka Pharmaceutical Co., Ltd.
A61K31/496A61K9/0019A61K9/10A61K45/06A61K47/26A61P25/00A61K9/19
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Quick Facts
Patent No.
US 10,980,803
App. No.
16/710,495
Granted
Apr 20, 2021
Kind
B2
Abstract

The disclosed embodiments relate to methods of initiating aripiprazole treatment in a patient who is a CYP2D6 poor metabolizer or a CYP3A4 poor metabolizer, or both.

Claims (38)

1. A method of treating schizophrenia in a patient comprising:

intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of about 300 mg or of aripiprazole prodrug of about 441 mg,

wherein the dose is systemically released over a period of about one month, and the patient is a CYP2D6 poor metabolizer.

2. The method of claim 1 , wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle.

3. The method of claim 2 , wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle.

4. The method of claim 1 , wherein the aripiprazole prodrug is 7-(4-(4-(2,3-dichlorophenyl)piperazin-l-yl)butoxy)-2-oxo-3,4-dihydroquinolin-l(2H)-yl)methyl dodecanoate.

5. The method of claim 1 , wherein the patient is not concomitantly administered a strong CYP3A4 inhibitor or a strong CYP2D6 inhibitor.

6. A method of treating schizophrenia in a patient comprising:

intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 200 mg,

wherein the dose is systemically released over a period of about one month and the patient is a CYP2D6 poor metabolizer concomitantly taking a CYP3A4 inhibitor.

7. The method of claim 6 , wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle.

8. The method of claim 7 , wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle.

9. A method of treating schizophrenia in a patient comprising:

intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 300 mg or of aripiprazole prodrug of 441 mg,

wherein the dose is systemically released over a period of about one month, and the patient has concomitant use of a strong CYP2D6 or CYP3A4 inhibitor and where an initial recommended dose for a patient with normal CYP2D6 or CYP3A4 enzyme function is 400 mg of aripiprazole or 662 mg of aripiprazole prodrug.

10. The method of claim 9 , wherein the patient is a CYP2D6 and CYP3A4 extensive metabolizer.

11. The method of claim 9 , wherein the patient's concomitant use of a strong CYP2D6 inhibitor or a strong CYP3A4 inhibitor is for at least 14 days.

12. The method of claim 9 , wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle.

13. The method of claim 11 , wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle.

14. A method of treating schizophrenia in a patient comprising:

intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 200 mg,

wherein the patient has concomitant use of CYP2D6 and CYP3A4 inhibitors, where an initial recommended dose for a patient with normal CYP2D6 or CYP3A4 enzyme function is 400 mg, and the dose is systemically released over a period of about one month.

15. The method of claim 14 , wherein the patient's concomitant use of CYP2D6 and a CYP3A4 inhibitors is for at least 14 days.

16. The method of claim 14 , wherein the patient is a CYP2D6 and CYP3A4 extensive metabolizer.

17. The method of claim 14 , wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle.

18. The method of claim 17 , wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle.

19. A method of treating schizophrenia in a patient comprising:

intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 198 mg,

wherein the patient has concomitant use of a strong CYP2D6 or CYP3A4 inhibitor, where an initial recommended dose for a patient with normal CYP2D6 or CYP3A4 enzyme function is 300 mg, and the dose is systemically released over a period of about one month.

20. The method of claim 19 , wherein the patient's concomitant use of a strong CYP2D6 or CYP3A4 inhibitor is for at least 14 days.

21. The method of claim 19 , wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle.

22. The method of claim 21 , wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle.

23. A method of treating schizophrenia in a patient comprising:

intramuscularly administering to the patient a long-acting suspension of an adjusted dose of aripiprazole of 159 mg,

wherein the patient has concomitant use of CYP2D6 and CYP3A4 inhibitors, where an initial recommended dose for a patient with normal CYP2D6 or CYP3A4 enzyme function is 300 mg of aripiprazole, and the dose is systemically released over a period of about one month.

24. The method of claim 23 , wherein the patient's concomitant use of CYP2D6 and CYP3A4 inhibitors is for at least 14 days.

25. The method of claim 23 , wherein the step of intramuscularly administering is in the patient's deltoid or gluteal muscle.

26. The method of claim 25 , wherein the gluteal muscle is chosen from ventrogluteal muscle and dorsogluteal muscle.

Continuity (2)
Continuation 14034727 · Sep 24, 2013
Related Publication 20200360370A1 · Nov 19, 2020
Cited By (2)
US 12,433,887 US 12,691,056