IP Library Granted Patent US 10,525,057
Granted Patent B2
US 10,525,057 · App. 14/034,727 · Granted Jan 7, 2020

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

Inventor: Arash Raoufinia (Vienna, VA)
Assignee: Otsuka Pharmaceutical Co., Ltd.
A61K31/496A61K45/06
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Quick Facts
Patent No.
US 10,525,057
App. No.
14/034,727
Granted
Jan 7, 2020
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 (20)

1. A method of initiating systemic aripiprazole treatment in a patient, comprising initially intramuscularly administering to the patient 66% to 75% of a 300 or 400 mg weight equivalent dose of aripiprazole in the form of a long-acting drug-containing suspension which systemically releases aripiprazole, wherein the dose is released over a period of about one month, and wherein the patient is a CYP2D6 and CYP3A4 extensive metabolizer and is concomitantly administered a strong CYP2D6 inhibitor or a strong CYP3A4 inhibitor.

2. The method of claim 1 , wherein 66% to 75% of a 300 mg weight equivalent dose of aripiprazole is administered.

3. The method of claim 1 , wherein 66% of a 300 mg weight equivalent dose of aripiprazole is administered.

4. The method of claim 1 , wherein 66% to 75% of a 400 mg weight equivalent dose of aripiprazole is administered.

5. The method of claim 1 , wherein 75% of a 400 mg weight equivalent dose of aripiprazole is administered.

6. The method of claim 1 , wherein the long-acting drug-containing suspension comprises a prodrug of aripiprazole.

7. The method of claim 1 , wherein the long-acting drug-containing suspension comprises aripiprazole.

8. The method of claim 6 , wherein the long-acting drug-containing suspension comprises (7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquinolin-1(2H)-yl)methyl dodecanoate.

9. A method of initiating systemic aripiprazole treatment in a patient, comprising initially intramuscularly administering to the patient 75% of a 300 or 400 mg weight equivalent dose of aripiprazole in the form of a long-acting drug-containing suspension which systemically releases aripiprazole, wherein the dose is released over a period of about one month, and wherein the patient is a CYP2D6 poor metabolizer not concomitantly administered a strong CYP3A4 inhibitor or a strong CYP2D6 inhibitor.

10. The method of claim 9 , wherein 75% of a 300 mg weight equivalent dose of aripiprazole is administered.

11. The method of claim 9 , wherein 75% of a 400 mg weight equivalent dose of aripiprazole is administered.

12. The method of claim 9 , wherein the long-acting drug-containing suspension comprises a prodrug of aripiprazole.

13. The method of claim 9 , wherein the long-acting drug-containing suspension comprises aripiprazole.

14. The method of claim 12 , wherein the long-acting drug-containing suspension comprises (7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquinolin-1(2H)-yl)methyl dodecanoate.

15. A method of initiating systemic aripiprazole treatment in a patient, comprising initially intramuscularly administering to the patient 53% of a 300 mg or 50% of a 400 mg weight equivalent dose of aripiprazole in the form of a long-acting drug-containing suspension which systemically releases aripiprazole, wherein the dose is released over a period of about one month, and wherein the patient is a CYP2D6 and CYP3A4 extensive metabolizer and is concomitantly administered a strong CYP2D6 inhibitor and a strong CYP3A4 inhibitor.

16. The method of claim 15 , wherein 53% of a 300 weight equivalent dose of aripiprazole is administered.

17. The method of claim 15 , wherein 50% of a 400 mg weight equivalent dose of aripiprazole is administered.

18. The method of claim 15 , wherein the long-acting drug-containing suspension comprises a prodrug of aripiprazole.

19. The method of claim 15 , wherein the long-acting drug-containing suspension comprises aripiprazole.

20. The method of claim 18 , wherein the long-acting drug-containing suspension comprises (7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquinolin-1(2H)-yl)methyl dodecanoate.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 30, 2014
From: MCQUADE, ROBERT; RAOUFINIA, ARASH
To: OTSUKA PHARMACEUTICAL CO., LTD.
Reel/Frame 033071/0910 →
Continuity (1)
Related Publication 20150087654A1 · Mar 26, 2015
Cited By (2)
US 12,433,887 US 12,691,056