Granted Patent B2

US 12,544,345 · App. 19/249,959 · Granted Feb 10, 2026

Inventor: Herriot Tabuteau (New York, NY)

Assignee: ANTECIP BIOVENTURES LL LLC

A61K31/137A61K9/2009A61K9/2013A61K9/2027A61K9/2054A61K9/2086A61K31/135A61K31/4525A61K31/485A61P25/24G01N33/942A61K9/20G01N2800/52

Abstract

Claims (23)

1 . A method of treating agitation associated with Alzheimer's disease in a human patient who requires concomitant treatment with a strong CYP2D6 inhibitor, comprising administering, once daily to the human patient, a combination of bupropion hydrochloride and dextromethorphan hydrobromide, wherein the human patient is experiencing agitation associated with Alzheimer's disease and is receiving concomitant treatment with the strong CYP2D6 inhibitor, wherein dextromethorphan hydrobromide and bupropion hydrochloride are the only active agents in the combination, and wherein the strong CYP2D6 inhibitor is (S)-Duloxetine.

2 . The method of claim 1 , wherein the combination comprises about 105 mg of bupropion hydrochloride and about 45 mg of dextromethorphan hydrobromide and is present in a solid oral dosage form.

3 . The method of claim 2 , wherein the once-daily administration avoids the human patient having an increase in AUC 0-12 of dextromethorphan as compared to the AUC 0-12 of dextromethorphan that would result after twice daily administration of the solid dosage form for the same number of days to the human patient without the concomitant treatment with the strong CYP2D6 inhibitor.

4 . The method of claim 2 , wherein the once-daily administration avoids the patient having an increase in C max of dextromethorphan as compared to the C max of dextromethorphan that would result after twice daily administration of the solid dosage form for the same number days to the human patient without the concomitant treatment with the strong CYP2D6 inhibitor.

5 . The method of claim 2 , wherein the solid dosage form is orally administered in the morning.

6 . The method of claim 5 , wherein the dextromethorphan is in an immediate-release formulation.

7 . The method of claim 6 , wherein the bupropion is in an extended-release formulation.

8 . The method of claim 7 , wherein the once-daily administration avoids the human patient having an increase in AUC 0-12 of dextromethorphan as compared to the AUC 0-12 of dextromethorphan that would result after twice daily administration of the solid dosage form for the same number of days to the human patient without the concomitant treatment with the strong CYP2D6 inhibitor.

9 . The method of claim 7 , wherein the once-daily administration avoids the patient having an increase in C max of dextromethorphan as compared to the C max of dextromethorphan that would result after twice daily administration of the solid dosage form for the same number of days to the human patient without the concomitant treatment with the strong CYP2D6 inhibitor.

10 . The method of claim 7 , wherein the solid dosage form further contains a carbomer homopolymer.

11 . The method of claim 7 , wherein the solid dosage form further contains colloidal silicon dioxide.

12 . The method of claim 7 , wherein the solid dosage form further contains crospovidone.

13 . The method of claim 7 , wherein the solid dosage form further contains glyceryl monocaprylocaprate.

14 . The method of claim 7 , wherein the solid dosage form further contains L-cysteine hydrochloride monohydrate.

15 . The method of claim 7 , wherein the solid dosage form further contains magnesium stearate.

16 . The method of claim 7 , wherein the solid dosage form further contains microcrystalline cellulose.

17 . The method of claim 7 , wherein the solid dosage form further contains polyvinyl alcohol.

18 . The method of claim 7 , wherein the solid dosage form further contains red iron oxide.

19 . The method of claim 7 , wherein the solid dosage form further contains sodium lauryl sulfate.

20 . The method of claim 7 , wherein the solid dosage form further contains stearic acid.

21 . The method of claim 7 , wherein the solid dosage form further contains talc.

22 . The method of claim 7 , wherein the solid dosage form further contains titanium dioxide.

23 . The method of claim 7 , wherein the solid dosage form further contains yellow iron oxide.

Assignments (1)

Continuity (9)

References Cited (400)