Dosing regimen for missed doses for long-acting injectable paliperidone esters

• US 10,143,693 B2
• Filed: 04/05/2016
• Issued: 12/04/2018
• Est. Priority Date: 04/07/2015
• Status: Active Grant

• Current Assignee: Janssen Pharmaceutica NV (Johnson & Johnson)
• Original Assignee: Janssen Pharmaceuticals, Inc. (Johnson & Johnson)
• Inventors: Gopal, Srihari, Ravenstijn, Paulien Gerarda Maria, Russu, Alberto, Samtani, Mahesh Narain
• Primary Examiner(s): Baek, Bong-Sook
• Application Number:
  US15/090,889
• Publication Number:
  US 20170281629A1
• Time in Patent Office: 973 Days
• Field of Search: None
• CPC Class Codes: A61K 31/519 ortho- or peri-condensed with heterocyclic rings
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/24 Antidepressants

Abstract

The present application provides a method for treating patients in need of psychiatric treatment, wherein said patient is being treated with the 3-month formulation of paliperidone palmitate and fails to take the next scheduled dose of the 3-month formulation of paliperidone palmitate.

Claims

1. A dosing regimen for administering an injectable paliperidone palmitate depot to a patient in need of treatment for psychosis, schizophrenia or bipolar disorder that has been treated with a 3-month injectable paliperidone palmitate depot (PP3M), wherein said patient had been last administered a PP3M injection more than 9 months ago, and the next scheduled maintenance dose of the PP3M should be administered to said patient, comprising:

(1) administering intramuscularly in the deltoid muscle of said patient a first reinitiation loading dose of 150 mg eq. of monthly injectable paliperidone palmitate depot (PP1M);

(2) administering intramuscularly in the deltoid muscle of said patient a second reinitiation loading dose of 100 mg eq. of PP1M on about the 4th day to about the 12th day after administering said first reinitiation loading dose;

(3) administering intramuscularly in the deltoid or gluteal muscle of said patient a first reinitiation maintenance dose of 50 mg eq. to about 150 mg eq. of PP1M on about the 23th day to about the 37th day after administering said second reinitiation loading dose;

(4) administering intramuscularly in the deltoid or gluteal muscle of said patient a second reinitiation maintenance dose of from about 50 mg eq. to about 150 mg eq. of PP1M on about the 23rd day to about the 37th day after administering of the first reinitiation maintenance dose;

(5) administering intramuscularly in the deltoid or gluteal muscle of said patient a third reinitiation maintenance dose of from about 50 mg eq. to about 150 mg eq. of PP1M on about the 23rd day to about the 37th day after administering of the second reinitiation maintenance dose; and

(6) administering intramuscularly in the deltoid or gluteal muscle of said patient from about 175 mg eq. to about 525 mg eq. of PP3M on about the 23rd day to about the 37th day after administering of the last reinitiation maintenance dose of monthly injectable paliperidone palmitate.

2. The method of claim 1, wherein said patient is in need of treatment for psychosis.

3. The method of claim 1, wherein said patient is in need of treatment for schizophrenia.

4. The method of claim 1, wherein said patient is in need of treatment for bipolar disorder.

15. The method of claim 1 wherein the second reinitiation loading dose of PP1M is administered about 7 days after administering said first reinitiation loading dose of PP1M.

16. The method of claim 15 wherein the second reinitiation loading dose of PP1M is administered 7 days after administering said first reinitiation loading dose of PP1M.

17. The method of claim 1 wherein the first reinitiation maintenance dose of PP1M is administered about 30 days after administering said second reinitiation loading dose of PP1M.

18. The method of claim 1 wherein the first reinitiation maintenance dose of PP1M is administered 30 days after administering said second reinitiation loading dose of PP1M.

19. The method of claim 1 wherein the second reinitiation maintenance of PP1M is administered about 30 days after administering said first reinitiation maintenance dose of PP1M.

20. The method of claim 1 wherein the second reinitiation maintenance of PP1M is administered 30 days after administering said first reinitiation maintenance dose of PP1M.

21. The method of claim 1 wherein the third reinitiation maintenance of PP1M is administered about 30 days after administering said second reinitiation maintenance dose of PP1M.

22. The method of claim 1 wherein the third reinitiation maintenance of PP1M is administered 30 days after administering said second reinitiation maintenance dose of PP1M.

23. The method of claim 1 wherein PP3M is administered about 30 days after administering said last reinitiation maintenance of PP1M.

24. The method of claim 1 wherein PP3M is administered 30 days after administering said last reinitiation maintenance of PP1M.

25. The method of claim 1 wherein PP3M is administered about a month after administering said last reinitiation maintenance of PP1M.

26. The method of claim 1 wherein PP3M is administered a month after administering said last reinitiation maintenance of PP1M.

27. The method of claim 1 further comprising administering intramuscularly in the deltoid or gluteal muscle of said patient a fourth reinitiation maintenance dose of from about 50 mg eq. to about 150 mg eq. of PP1M on about the 23rd day to about the 37th day after administering the third reinitiation maintenance dose.

28. The method of claim 27 wherein said fourth reinitiation maintenance of PP1M is administered about 30 days after administering said third reinitiation maintenance dose of PP1M.

29. The method of claim 28 wherein said fourth reinitiation maintenance of PP1M is administered 30 days after administering said third reinitiation maintenance dose of PP1M.

5. A dosing regimen for administering an injectable paliperidone palmitate depot to a patient in need of treatment for psychosis, schizophrenia or bipolar disorder that has been treated with PP3M, wherein said patient had been last administered a PP3M injection 4 to 9 months ago and the next scheduled maintenance dose of PP3M should be administered to said patient, comprising:

(1) administering intramuscularly in the deltoid muscle of said patient a first reinitiation loading dose of PP1M;

(2) administering intramuscularly in the deltoid muscle of said patient a second reinitiation loading dose of PP1M on about the 4th day to about the 12th day after administering of said first reinitiation loading dose; and

(3) administering intramuscularly in the deltoid or gluteal muscle of said patient a reinitiation dose of PP3M on about the 23rd day to about the 37th day after administering the second reinitiation loading dose of PP1M wherein said first and second reinitiation loading doses and the reinitiation PP3M dose are selected from the table below based on the amount of the missed dose

6. The method of claim 5, wherein said patient is in need of treatment for psychosis.

7. The method of claim 5, wherein said patient is in need of treatment for schizophrenia.

8. The method of claim 5, wherein said patient is in need of treatment for bipolar disorder.

9. The method of claim 5 wherein the second reinitiation dose of PP1M is administered about 7 days after administering said first reinitiation loading dose of PP1M.

10. The method of claim 9 wherein the second reinitiation dose of PP1M is administered 7 days after administering said first reinitiation loading dose of PP1M.

11. The method of claim 5 wherein the reinitiation dose of PP3M is administered about 30 days after administering said second reinitiation loading dose of PP1M.

12. The method of claim 11 wherein the reinitiation dose of PP3M is administered 30 days after administering said second reinitiation loading dose of PP1M.

13. The method of claim 5 wherein the reinitiation dose of PP3M is administered about a month after administering said second reinitiation loading dose of PP1M.

14. The method of claim 11 wherein the reinitiation dose of PP3M is administered a month after administering said second reinitiation loading dose of PP1M.