Iloperidone for the treatment of schizophrenia

Patent metadata

Field	Value
Publication number	US-10441580-B2
Application number	US-201615549820-A
Country	US
Kind code	B2
Filing date	Feb 17, 2016
Priority date	Feb 17, 2015
Publication date	Oct 15, 2019
Grant date	Oct 15, 2019

Abstract

Aspects of the invention relate generally to the treatment of schizophrenia in an individual and, more specifically, to the treatment of an individual with iloperidone, an iloperidone metabolite, or a pharmaceutically-acceptable salt thereof. In one embodiment, the invention provides a method of preventing schizophrenic relapse in an individual diagnosed with schizophrenia, the method comprising: administering to the individual iloperidone, an iloperidone metabolite, or a pharmaceutically-acceptable salt thereof at a daily dose between about 12 mg and about 16 mg following a period in which the individual's schizophrenia was stabilized.

First claim

The invention claimed is:

1. A method of treating schizophrenia or a symptom of schizophrenia in an individual, the method comprising:
administering to the individual a titrated first daily dose of 16-24 mg/day of iloperidone or a pharmaceutically-acceptable salt thereof during an acute treatment phase, wherein the acute treatment phase follows an initial titration of iloperidone,
followed by administering to the individual a second daily dose that is smaller than the titrated first daily dose and is 12-16 mg/day of iloperidone or a pharmaceutically-acceptable salt thereof during a maintenance treatment phase, following completion of the acute treatment phase.

2. The method of claim 1 , wherein the titrated first daily dose is 8-12 mg of iloperidone administered orally twice daily, and the second daily dose is 6-8 mg of iloperidone administered orally twice daily.

3. The method of claim 1 , wherein the second daily dose is 75% of the first daily dose.

4. The method of claim 1 , wherein the titrated first daily dose is 16 mg and the second daily dose is 12 mg.

5. The method of claim 1 , wherein the titrated first daily dose is 12 mg and the second daily dose is 8 mg.

6. The method of claim 1 , wherein the second daily dose is 50% of the first daily dose.

7. The method of claim 6 , wherein the titrated first daily dose is 24 mg and the second daily dose is 12 mg.

8. The method of claim 6 , wherein the titrated first daily dose is 16 mg and the second daily dose is 8 mg.

9. The method of claim 6 , wherein the titrated first daily dose is 12 mg and the second daily dose is 6 mg.

10. The method of claim 1 , wherein the second daily dose is between 12 mg and 16 mg.

11. The method of claim 10 , wherein the second daily dose is between 12 mg and 14 mg.

12. A method of continuing the treatment of schizophrenia in an individual who has been receiving a titrated first daily dose of 16-24 mg/day of iloperidone or a pharmaceutically acceptable salt thereof during an acute treatment phase of the schizophrenia, the method comprising:
administering a second daily dose of 12-16 mg/day of iloperidone or the pharmaceutically acceptable salt thereof that is reduced relative to the first daily dose during a subsequent maintenance treatment phase following completion of the acute treatment phase.

13. The method of claim 12 , wherein the titrated first daily dose of iloperidone or the pharmaceutically acceptable salt thereof is 8-12 mg administered twice daily, and the second daily dose of iloperidone or the pharmaceutically acceptable salt thereof is 6-8 mg administered twice daily.

14. The method of claim 12 , wherein the second daily dose is 75% of the first daily dose.

15. The method of claim 14 , wherein the first daily dose is 16 mg and the second daily dose is 12 mg/day.

16. The method of claim 14 , wherein the first daily dose is 20 mg and the second daily dose is 15 mg/day.

17. The method of claim 12 , wherein the first daily dose is 24 mg and the second daily dose is 16 mg.

18. The method of claim 12 , wherein the second daily dose is 50% of the first daily dose.

19. The method of claim 18 , wherein the first daily dose is 24 mg and the second daily dose is 12 mg/day.

20. The method of claim 12 , wherein the second daily dose is between 12 mg and 14 mg/day.

Assignees

• Vanda Pharmaceuticals Inc

Inventors

• Polymeropoulos Mihael H
• Wolfgang Curt D

Classifications

• A61P25/18

  Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia · CPC title

• A61K31/454 Primary

  containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone · CPC title

• A61K31/423

  condensed with carbocyclic rings · CPC title

• A61K9/0053

  Mouth and digestive tract, i.e. intraoral and peroral administration · CPC title