Claims for Patent: 11,129,826

Summary for Patent: 11,129,826

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):	Tabuteau; Herriot (New York, NY)
Assignee:	AXSOME THERAPEUTICS, INC. (New York, NY)
Application Number:	17/070,706
Patent Claims:	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.