IP Library Granted Patent US 11,969,421
Granted Patent B2
US 11,969,421 · App. 17/841,274 · Granted Apr 30, 2024

Bupropion as a modulator of drug activity

Inventor: Herriot Tabuteau (New York, NY)
Assignee: Antecip Bioventures II LLC
A61K31/485A61K9/0053A61K31/135A61K31/137A61K31/15A61K31/343A61K31/381
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Quick Facts
Patent No.
US 11,969,421
App. No.
17/841,274
Granted
Apr 30, 2024
Kind
B2
Abstract

Disclosed herein are methods of treating neurological or psychiatric diseases or disorders using a combination of bupropion and dextromethorphan. Related compositions and dosage forms are also described.

Claims (29)

1. A method of treating major depressive disorder, comprising administering a dosage form by mouth once daily or twice daily to a human patient in need thereof, wherein the dosage form comprises about 105 mg of bupropion hydrochloride and about 45 mg of a dextromethorphan salt as the only therapeutically active compounds in the dosage form, wherein the human patient does not experience an adverse event as a result of receiving the dosage form, and wherein the adverse event is decreased appetite.

2. The method of claim 1 , wherein the dosage form is a tablet.

3. The method of claim 1 , wherein bupropion hydrochloride is in a sustained release formulation.

4. The method of claim 3 , wherein the dextromethorphan salt is in an immediate release formulation.

5. The method of claim 1 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the C max of bupropion in the human patient is about 9×10 1 ng/mL.

6. The method of claim 1 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the AUC 0-12 of bupropion in the human patient is about 7×10 2 ng·hr/mL.

7. The method of claim 1 , wherein the dextromethorphan salt is dextromethorphan hydrobromide.

8. The method of claim 7 , wherein the dosage form is a tablet.

9. The method of claim 7 , wherein bupropion hydrochloride is in a sustained release formulation.

10. The method of claim 9 , wherein dextromethorphan hydrobromide is in an immediate release formulation.

11. The method of claim 7 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the C max of bupropion in the human patient is about 9×10 1 ng/mL.

12. The method of claim 7 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the AUC 0-12 of bupropion in the human patient is about 7×10 2 ng·hr/mL.

13. The method of claim 7 , wherein the human patient is an extensive CYP2D6 metabolizer.

14. The method of claim 13 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter.

15. The method of claim 1 , wherein the human patient is an extensive CYP2D6 metabolizer.

16. The method of claim 15 , wherein the dosage form is a tablet.

17. The method of claim 15 , wherein bupropion hydrochloride is in a sustained release formulation.

18. The method of claim 17 , wherein the dextromethorphan salt is in an immediate release formulation.

19. The method of claim 15 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the C max of bupropion in the human patient is about 9×10 1 ng/mL.

20. The method of claim 15 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the AUC 0-12 of bupropion in the human patient is about 7×10 2 ng·hr/mL.

21. The method of claim 1 , wherein the dosage form is administered once daily by mouth for three days followed by twice daily by mouth thereafter.

22. The method of claim 21 , wherein the human patient is an extensive CYP2D6 metabolizer.

23. The method of claim 21 , wherein the dosage form is a tablet.

24. The method of claim 21 , wherein bupropion hydrochloride is in a sustained release formulation.

25. The method of claim 24 , wherein the dextromethorphan salt is in an immediate release formulation.

26. The method of claim 23 wherein the dosage form is administered for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the C max of bupropion in the human patient is about 9×10 1 ng/mL.

27. The method of claim 23 wherein the dosage form is administered for a total of at least 8 days, and wherein on the eighth day that the dosage form is administered, the AUC 0-12 of bupropion in the human patient is about 7×10 2 ng·hr/mL.

28. A method of treating major depressive disorder, comprising administering a dosage form by mouth once daily or twice daily to a human patient in need thereof, wherein the dosage form consists essentially of about 105 mg of bupropion hydrochloride and about 45 mg of a dextromethorphan salt, wherein the human patient does not experience an adverse event as a result of receiving the dosage form, and wherein the adverse event is decreased appetite.

29. A method of treating major depressive disorder, comprising orally administering a dosage form no more than twice daily to a human patient in need thereof, wherein the therapeutically active compounds in the dosage form consist of (i) about 105 mg of bupropion hydrochloride and (ii) about 45 mg of a dextromethorphan salt, wherein the human patient does not experience an adverse event as a result of receiving the dosage form, and wherein the adverse event is decreased appetite.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 24, 2022
From: TABUTEAU, HERRIOT
To: ANTECIP BIOVENTURES II LLC
Reel/Frame 060888/0241 →
Continuity (20)
Continuation 17468149 · Sep 7, 2021
Continuation In Part 17194739 · Mar 8, 2021
Continuation In Part 17068309 · Oct 12, 2020
Continuation In Part 16822697 · Mar 18, 2020
Continuation In Part 16817119 · Mar 12, 2020
Continuation In Part 16359958 · Mar 20, 2019
Continuation In Part 16359996 · Mar 20, 2019
Continuation In Part 15821563 · Nov 22, 2017
Continuation In Part 15645939 · Jul 10, 2017
Continuation In Part 15263138 · Sep 12, 2016
Continuation 15164746 · May 25, 2016
Continuation In Part 14879002 · Oct 8, 2015
Continuation 14554988 · Nov 26, 2014
Continuation 14550618 · Nov 21, 2014
Continuation In Part PCTUS2014064184 · Nov 5, 2014
Provisional Application 63224323 · Jul 21, 2021
Provisional Application 62645751 · Mar 20, 2018
Provisional Application 62576538 · Oct 24, 2017
Provisional Application 61900354 · Nov 5, 2013
Related Publication 20220313689A1 · Oct 6, 2022
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