Granted Patent B2

US 12,472,156 · App. 19/204,307 · Granted Nov 18, 2025

Inventor: Herriot Tabuteau (New York, NY)

Assignee: Antecip Bioventures II LLC

A61K31/138A61K9/0053A61K31/137A61K31/485A61P25/24

Abstract

Claims (18)

1 . A method of treating agitation associated with Alzheimer's disease, comprising administering a first dosage form once daily for one week, to a human patient in need thereof, and then administering the first dosage form twice daily to the human patient for one week, wherein the first dosage form comprises 30 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan, and 105 mg of bupropion hydrochloride, or a molar equivalent amount of another salt form of bupropion, and wherein the first dosage form provides an immediate release of the dextromethorphan.

2 . The method of claim 1 , wherein after the first dosage form is administered once daily for one week followed by twice daily for one week to the human patient, the method further comprises administering a second dosage form twice daily to the human patient for at least one week, wherein the second dosage form comprises 45 mg of dextromethorphan hydrobromide, or a molar equivalent amount of another salt form of dextromethorphan or the free base form of dextromethorphan, and 105 mg of bupropion hydrochloride, or a molar equivalent amount of another salt form of bupropion or the free base form of bupropion, and wherein the second dosage form provides sustained release of the bupropion.

3 . The method of claim 2 , wherein the second dosage form is administered twice daily for at least three weeks.

4 . The method of claim 1 , wherein the human patient has an age of 65 years to 90 years.

5 . The method of claim 1 , wherein the human patient has a diagnosis of probable Alzheimer's disease according to the 2011 NIA-AA criteria.

6 . The method of claim 1 , wherein the human patient has a diagnosis of agitation according to the IPA provisional definition of agitation.

7 . The method of claim 1 , wherein the human patient has a Mini-Mental State Examination score between 10 and 24.

8 . The method of claim 1 , wherein the human patient has a Neuropsychiatric Inventory-Agitation and Aggressive domain score of 4 or greater.

9 . The method of claim 1 , wherein the human patient is community dwelling.

10 . The method of claim 1 , wherein the human patient is not receiving a concomitant selective serotonin reuptake inhibitor.

11 . The method of claim 1 , wherein the human patient is not receiving a concomitant serotonin and norepinephrine inhibitor.

12 . The method of claim 1 , wherein the human patient is not experiencing a dementia of non-Alzheimer's type.

13 . The method of claim 2 , wherein both the first dosage form and the second dosage form provide sustained release of bupropion.

14 . The method of claim 2 , wherein both the first dosage form and the second dosage form provide immediate release of dextromethorphan.

15 . The method of claim 1 , wherein the first dosage form contains 30 mg of dextromethorphan hydrobromide.

16 . The method of claim 15 , wherein the first dosage form contains 105 mg of bupropion hydrochloride.

17 . The method of claim 2 , wherein the second dosage form contains 45 mg of dextromethorphan hydrobromide.

18 . The method of claim 17 , wherein the second dosage form contains 105 mg of bupropion hydrochloride.

Assignments (1)

Continuity (10)

References Cited (400)

Cited By (3)

US 12,653,795 US 12,661,408 US 12,678,506