IP Library Granted Patent US 12,390,428
Granted Patent B2
US 12,390,428 · App. 18/397,220 · Granted Aug 19, 2025

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 12,390,428
App. No.
18/397,220
Granted
Aug 19, 2025
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 a score of at least 35 on the Montgomery-Åsberg Depression Rating Scale (MADRS), 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 a 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 1 , wherein the combination is administered twice a day for at least two weeks.

5. The method of claim 1 , 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-to about 25-fold as compared to administration of a single dose 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-to about 45-fold as compared to administering a single dose 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-to about 45-fold as compared to administering a single dose 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 (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 21, 2024
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 067487/0445 →
Cited By (7)
US 12,544,345 US 12,564,587 US 12,576,078 US 12,599,576 US 12,653,795 US 12,661,408 US 12,678,506