IP Library Granted Patent US 11,129,826
Granted Patent B2
US 11,129,826 · App. 17/070,706 · Granted Sep 28, 2021

Bupropion as a modulator of drug activity

Inventor: Herriot Tabuteau (New York, NY)
Assignee: AXSOME THERAPEUTICS, INC.
A61K31/485A61K9/0053A61K31/135A61K31/137A61K31/15A61K31/343A61K31/381
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Quick Facts
Patent No.
US 11,129,826
App. No.
17/070,706
Granted
Sep 28, 2021
Kind
B2
Abstract

Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Claims (23)

1. A method of treating depression, comprising administering a drug combination comprising: a daily dose of bupropion that is about 200 mg to about 250 mg and a daily dose of dextromethorphan that is about 80 mg to about 100 mg, to a human being in need thereof for at least 8 consecutive days, wherein the bupropion and the dextromethorphan are present in a dosage form, wherein the bupropion and the dextromethorphan are the only therapeutically active compounds in the dosage form; wherein administering the drug combination results in a therapeutic effect upon the human being; wherein the daily doses of the bupropion and the dextromethorphan are orally administered once a day or are a total of twice daily doses; and wherein the dosage form is formulated for immediate release of dextromethorphan and sustained release of bupropion.

2. The method of claim 1 , wherein the human being experiences an improvement in a depressive symptom as compared to baseline.

3. The method of claim 1 , wherein orally administering the dosage form is more effective in treating depression than a placebo.

4. The method of claim 1 , wherein orally administering the dosage form is more effective in treating depression than orally administering the same amount of the dextromethorphan alone.

5. The method of claim 1 , wherein the dosage form is orally administered once daily.

6. The method of claim 1 , wherein the dosage form is orally administered twice daily.

7. The method of claim 1 , wherein the dosage form is orally administered for at least 14 consecutive days.

8. The method of claim 1 , wherein the dosage form is orally administered for at least 30 consecutive days.

9. The method of claim 1 , wherein the weight ratio of the dextromethorphan to the bupropion in the dosage form is about 0.3 to about 0.5.

10. The method of claim 1 , wherein the dosage form is solid.

11. The method of claim 1 , wherein the dosage form is orally administered once a day for 1 day and is administered twice a day thereafter.

12. The method of claim 1 , wherein the dosage form is orally administered once a day for 2 days and is administered twice a day thereafter.

13. The method of claim 1 , wherein the dosage form is orally administered once a day for 3 days and is administered twice a day thereafter.

14. The method of claim 1 , wherein the human being suffers from anxiety, and orally administering the dosage form is more effective than a placebo in reducing anxiety.

15. The method of claim 1 , wherein the human being suffers from difficulty concentrating, mental slowing, or a combination thereof, and orally administering the dosage form is more effective than a placebo in improving concentration, reducing mental slowing, or a combination thereof.

16. The method of claim 1 , wherein the human being suffers from feelings of intense sadness, despair, pessimistic worry, or a combination thereof, and orally administering the dosage form is more effective than a placebo in improving mood, reducing feelings of intense sadness, reducing despair, reducing pessimistic worry, or a combination thereof.

17. The method of claim 1 , wherein the human being suffers from agitation, irritability, restlessness, or a combination thereof, and orally administering the dosage form is more effective than a placebo in reducing agitation, irritability, restlessness, or a combination thereof.

18. The method of claim 1 , wherein the human being suffers from guilt, feelings of worthlessness, self-deprecation, or a combination thereof, and orally administering the dosage form is more effective than a placebo in reducing guilt, feelings of worthlessness, self-deprecation, or a combination thereof.

19. The method of claim 1 , wherein the human being suffers from insomnia, and orally administering the dosage form is more effective than a placebo in reducing insomnia.

20. The method of claim 1 , wherein the human being suffers from anorexia, appetite loss, weight loss, or a combination thereof, and orally administering the dosage form is more effective than a placebo in reducing anorexia, appetite loss, weight loss, or a combination thereof.

21. The method of claim 1 , wherein the human being suffers from weight gain, and orally administering the dosage form is more effective than a placebo in reducing weight gain.

22. The method of claim 1 , wherein the human being suffers from decreased energy, fatigue, decreased libido, or a combination thereof, and orally administering the dosage form is more effective than a placebo in reducing decreased energy, fatigue, decreased libido, or a combination thereof.

23. The method of claim 1 , wherein the human being suffers from abnormal hormonal circadian rhythms, and orally administering the dosage form is more effective than a placebo in reducing abnormal hormonal circadian rhythms.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 9, 2021
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 055189/0032 →