Claims for Patent: 11,524,008

Summary for Patent: 11,524,008

Title:	Bupropion as a modulator of drug activity
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.
Inventor(s):	Herriot Tabuteau
Assignee:	Antecip Bioventures II LLC
Application Number:	US17/735,470
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,524,008
Patent Claims:	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 constipation. 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 Cmax of bupropion in the human patient is about 9×101 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 AUC0-12 of bupropion in the human patient is about 7×102 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 Cmax of bupropion in the human patient is about 9×101 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 AUC0-12 of bupropion in the human patient is about 7×102 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 Cmax of bupropion in the human patient is about 9×101 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 AUC0-12 of bupropion in the human patient is about 7×102 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 Cmax of bupropion in the human patient is about 9×101 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 AUC0-12 of bupropion in the human patient is about 7×102 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 constipation. 29. A method of treating major depressive disorder, comprising orally administering to a human patient in need thereof once daily or twice daily a dosage form comprising therapeutically active compounds, 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 constipation.