IP Library Granted Patent US 11,896,563
Granted Patent B2
US 11,896,563 · App. 18/323,714 · Granted Feb 13, 2024

Bupropion and dextromethorphan for reduction of suicide risk in depression patients

Inventor: Herriot Tabuteau (New York, NY)
Assignee: Antecip Bioventures II LLC
A61K31/137A61K31/485A61P25/24
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Quick Facts
Patent No.
US 11,896,563
App. No.
18/323,714
Granted
Feb 13, 2024
Kind
B2
Abstract

This disclosure relates to a method of treating depression and/or reducing risk of suicide, comprising administering a combination of about 90 mg to about 120 mg of bupropion hydrochloride, or a molar equivalent amount of another form of bupropion, and about 40 mg to about 50 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another form of dextromethorphan. The combination may be administered twice a day to a human being suffering from major depressive disorder and having a score of 3 or greater on the Suicidality Item of the Montgomery-Åsberg Depression Rating Scale (MADRS-SI).

Claims (17)

1. A method of treating depression and reducing risk of suicide, comprising: selecting a human being suffering from major depressive disorder and having a score of 3 or greater on the Suicidality Item of the Montgomery-Åsberg Depression Rating Scale (MADRS-SI), and administering a combination of about 90 mg to about 120 mg of bupropion hydrochloride, or a molar equivalent amount of another form of bupropion, and about 40 mg to about 50 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another form of dextromethorphan, to the human being; wherein the combination is administered twice a day to the human being.

2. The method of claim 1 , wherein the combination comprises about 105 mg of bupropion hydrochloride, or a molar equivalent amount of another form of bupropion, and about 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another form of dextromethorphan.

3. The method of claim 1 , wherein the combination is administered twice a day for at least one week.

4. The method of claim 3 , wherein the combination is administered twice a day for at least two weeks.

5. The method of claim 4 , wherein the combination is administered twice a day for at least six weeks.

6. The method of claim 1 , wherein the MADRS-SI of the human being is reduced by at least 30% after the combination is administered to the human being twice a day for one week.

7. The method of claim 1 , wherein the MADRS-SI of the human being is reduced by at least 50% after the combination is administered to the human being twice a day for two weeks.

8. The method of claim 1 , wherein the MADRS-SI of the human being is reduced by at least 60% after the combination is administered to the human being twice a day for four weeks.

9. The method of claim 1 , wherein after eight days of administration of the combination twice a day, the C max of dextromethorphan in the human being is increased about 15-fold to about 25-fold as compared to a single administration of the combination.

10. The method of claim 1 , wherein after eight days of administering the combination twice a day, the C min of dextromethorphan in the human being is increased about 35-fold to about 45-fold as compared to a single administration of the combination.

11. The method of claim 1 , wherein after eight days of administering the combination twice a day, the AUC 0-12 of dextromethorphan in the human being is increased about 25-fold to about 45-fold as compared to a single administration of the combination.

12. The method of claim 2 , wherein after eight days of administering the combination twice a day, the C max of dextromethorphan in the human being is about 75 ng/mL to about 80 ng/mL.

13. The method of claim 2 , wherein after eight days of administering the combination twice a day, the C min of dextromethorphan is about 42 ng/mL to about 50 ng/mL.

14. The method of claim 2 , wherein after eight days of administering the combination twice a day, the AUC 0-12 of dextromethorphan in the human being is about 755 ng·hr/mL.

15. The method of claim 2 , wherein after eight days of administering the combination twice a day, the C max of bupropion in the human being is about 85 ng/mL to about 90 ng/mL.

16. The method of claim 2 , wherein after eight days of administering the combination twice a day, the C min of bupropion is about 25 ng/mL to about 35 ng/mL.

17. The method of claim 2 , wherein after eight days of administering the combination twice a day, the AUC 0-12 of bupropion in the human being is about 660 ng·hr/mL to about 670 ng·hr/mL.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 13, 2023
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 064894/0543 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 23, 2023
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 064043/0505 →