ILOPERIDONE FOR THE TREATMENT OF SCHIZOPHRENIA

• US 20180021324A1
• Filed: 02/17/2016
• Published: 01/25/2018
• Est. Priority Date: 02/17/2015
• Status: Active Grant

• Current Assignee: Vanda Pharmaceuticals Incorporated
• Original Assignee: Vanda Pharmaceuticals Incorporated
• Inventors: Polymeropoulos, Mihael H., Wolfgang, Curt D.
• Granted Patent: US 10,441,580 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 31/454 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia

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.

Claims

1. A method of treating schizophrenia or a symptom of schizophrenia in an individual, the method comprising:

administering to the individual exhibiting at least one symptom of schizophrenia, a first daily dose of iloperidone, an iloperidone metabolite, 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 of iloperidone, an iloperidone metabolite, or a pharmaceutically-acceptable salt thereof during a maintenance treatment phase, once the individual is no longer exhibiting the at least one symptom of schizophrenia,

wherein the second daily dose is smaller than the first daily dose.

2. The method of claim 1, wherein the first daily dose is 16-24 mg/day of iloperidone, and the second daily dose is 12-16 mg/day of iloperidone.

3. The method of claim 2, wherein the 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.

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

5. The method of claim 2, wherein the first daily dose is about 16 mg and the second daily dose is about 12 mg.

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

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

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

9. The method of claim 7, wherein the first daily dose is about 16 mg and the second daily dose is about 8 mg.

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

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

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

13. 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.

14. The method of claim 13, wherein the daily dose is between about 12 mg and about 14 mg.

15. A method to maintain the effect of iloperidone for schizophrenia after response in an acute phase has been obtained, the method comprising:

administering to the individual a quantity of iloperidone, an iloperidone metabolite, or a pharmaceutically-acceptable salt thereof at a daily dose between about 12 mg and about 16 mg.

16. The method of claim 15, wherein administering occurs when at least one of the individual'"'"'s symptoms of schizophrenia has been alleviated.

17. The method of claim 15, wherein the individual was administered iloperidone at a higher daily dose during the acute phase.

18. The method of claim 16, wherein the higher daily dose was between about 12 mg and about 24 mg.