Claims for Patent: 10,925,842

Summary for Patent: 10,925,842

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:	US17/024,145
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,925,842
Patent Claims:	1. A method of treating major depressive disorder, comprising administering a drug combination to a human being in need thereof, wherein the drug combination comprises: a bupropion, in an amount that is about 105 mg of bupropion hydrochloride, or a molar equivalent amount of a bupropion in the free base form or another salt form, wherein the bupropion is administered once a day for the first three days and twice a day thereafter for at least 11 days; and a dextromethorphan, in an amount that is about 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of a dextromethorphan in the free base form or another salt form, wherein the dextromethorphan is administered once a day for the first three days and twice a day thereafter for at least 11 days; wherein the human being is selected for having received prior first line treatment in their current major depressive episode; and wherein the human being experiences a greater reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) score after receiving the drug combination, as compared to what would be experienced from receiving the same amount of the bupropion alone. 2. The method of claim 1, wherein administering the drug combination of the bupropion and the dextromethorphan is more effective in treating major depressive disorder than administering the same amount of the dextromethorphan alone. 3. The method of claim 1, wherein the drug combination comprising about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide is administered once a day for the first three days and twice a day thereafter for at least 11 days to the human being. 4. The method of claim 3, wherein administering the drug combination is more effective in treating major depressive disorder than administering 105 mg of bupropion hydrochloride once a day for the first three days and twice a day thereafter for at least 11 days. 5. The method of claim 1, wherein the dextromethorphan is formulated for immediate release. 6. The method of claim 1, wherein the bupropion is formulated for sustained release. 7. The method of claim 1, wherein the bupropion and the dextromethorphan are administered orally. 8. The method of claim 1, wherein the bupropion is in a solid dosage form. 9. The method of claim 1, wherein the dextromethorphan is in a solid dosage form. 10. The method of claim 1, wherein the human being has a Cavg of bupropion that is at least about 10 ng/mL after the drug combination is administered. 11. The method of claim 1, wherein the human being has a Cmax of bupropion that is at least about 90 ng/mL after the drug combination is administered. 12. The method of claim 1, wherein the human being has moderate major depressive disorder. 13. The method of claim 1, wherein the human being has severe major depressive disorder. 14. The method of claim 1, wherein the bupropion and the dextromethorphan are in a single dosage form. 15. The method of claim 1, wherein the bupropion and the dextromethorphan are in separate dosage forms. 16. The method of claim 1, wherein administration of the drug combination results in at least a 10% reduction in the MADRS score as compared with baseline. 17. The method of claim 1, wherein administration of the drug combination results in at least a 10% greater reduction in the MADRS score as compared to the reduction in the MADRS score that would result from administering placebo. 18. The method of claim 1, wherein the human being experiences at least a 10% greater reduction in the MADRS score, as compared to what the human being would experience from receiving placebo, within 2 weeks of first receiving the drug combination. 19. The method of claim 1, wherein the treatment effect on the human being is assessed within two weeks after the drug combination is first administered to the human being. 20. The method of claim 1, wherein the treatment effect on the human being is assessed within one week after the drug combination is first administered to the human being.