IP Library Granted Patent US 11,738,002
Granted Patent B2
US 11,738,002 · App. 17/228,796 · Granted Aug 29, 2023

Methods of treating neurological and psychiatric disorders

Inventors: Carrie A. Bowen (Uxbridge, MA); Seth Cabot Hopkins (Northborough, MA); Colleen M. Synan (Townsend, MA)
Assignee: Sunovion Pharmaceuticals Inc.
A61K31/381A61P25/18
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Quick Facts
Patent No.
US 11,738,002
App. No.
17/228,796
Granted
Aug 29, 2023
Kind
B2
Abstract

The present disclosure relates to methods of treating neurological or psychiatric diseases or disorders, such as schizophrenia. Compound 1, or a pharmaceutically acceptable salt thereof, is an antipsychotic agent with a non-D2 mechanism of action. Adverse events associated with antipsychotic agents that target the D2 dopamine receptor can be reduced by treating disorders with Compound 1, or a pharmaceutically acceptable salt thereof.

Claims (24)

1. A method of treating a neurological or psychiatric disease or disorder without decreasing sleep quality in a human patient in need thereof, comprising once daily orally administering to the patient a therapeutically effective amount of from 25 to 100 mg of Compound 1

or a pharmaceutically acceptable salt thereof at about bedtime.

2. The method of claim 1 , wherein the therapeutically effective amount comprises from 25 to 75 mg.

3. The method of claim 1 , wherein the neurological or psychiatric disease or disorder is selected from schizophrenia, depression, and anxiety.

4. The method of claim 1 , wherein the administration produces a C trough of 7.97-31.5 ng/mL after multiple administrations.

5. The method of claim 1 , wherein the administration produces a t max of 2.0-4.0 hours after single or multiple administrations.

6. The method of claim 1 , for treating the neurological or psychiatric disease or disorder in the patient continuously for a period of 6 months or more, comprising administering the therapeutically effective amount for 6 months or more.

7. A method of treating a neurological or psychiatric disease or disorder, in a human patient in need thereof, comprising once-daily administering to the patient a therapeutically effective amount of Compound 1

or a pharmaceutically acceptable salt thereof at about bedtime, so as to produce a t max of 2.0-4.0 hours after single or multiple administrations.

8. The method of claim 7 , wherein the neurological or psychiatric disease or disorder is selected from schizophrenia, depression, and anxiety.

9. The method of claim 7 , wherein the therapeutically effective amount comprises from 25 to 75 mg.

10. The method of claim 7 , wherein the administration produces a C trough of 7.97-31.5 ng/mL after multiple administrations.

11. The method of claim 7 , for treating the neurological or psychiatric disease or disorder in the patient continuously for a period of 6 months or more, comprising administering the therapeutically effective amount for 6 months or more.

12. The method of claim 7 , wherein the neurologic or psychiatric disease or disorder is schizophrenia in a patient having a PANSS total score <80.

13. The method of claim 7 , wherein the neurologic or psychiatric disease or disorder is depression.

14. The method of claim 7 , wherein the neurologic or psychiatric disease or disorder is anxiety.

15. The method of claim 11 , wherein the neurologic or psychiatric disease or disorder is schizophrenia in a patient having a PANSS total score <80.

16. The method of claim 11 , wherein the neurologic or psychiatric disease or disorder is depression.

17. The method of claim 11 , wherein the neurologic or psychiatric disease or disorder is anxiety.

18. A method of treating a neurological or psychiatric disease or disorder, in a human patient in need thereof, comprising once-daily administering to the patient a therapeutically effective amount of Compound 1

or a pharmaceutically acceptable salt thereof at about bedtime, so as to produce a C trough of 7.97-31.5 ng/mL after multiple administrations.

19. The method of claim 18 , wherein the neurological or psychiatric disease or disorder is selected from schizophrenia, depression, and anxiety.

20. The method of claim 18 , wherein the therapeutically effective amount comprises from 25 to 75 mg.

21. The method of claim 18 , for treating the neurological or psychiatric disease or disorder in the patient continuously for a period of 6 months or more, comprising administering the therapeutically effective amount for 6 months or more.

Assignments (2)
MERGER AND CHANGE OF NAME Recorded Jul 31, 2025
From: SUNOVION PHARMACEUTICALS INC.; SUMITOMO PHARMA AMERICA HOLDINGS, INC.
To: SUMITOMO PHARMA AMERICA, INC.
Reel/Frame 072292/0598 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 17, 2021
From: BOWEN, CARRIE A.; HOPKINS, SETH CABOT; SYNAN, COLLEEN M.
To: SUNOVION PHARMACEUTICALS INC.
Reel/Frame 056572/0045 →
Continuity (3)
Provisional Application 63039722 · Jun 16, 2020
Provisional Application 63009595 · Apr 14, 2020
Related Publication 20210315859A1 · Oct 14, 2021