# US 11,998,525 B2 · Compositions and methods for the treatment of depression

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- Number: US 11,998,525 B2
- Document ID: US11998525B2
- Status: Granted
- Kind: B2
- Application number: 18/188,894
- Filed: 2023-03-23
- Published: 2023-07-27
- Granted: 2024-06-04
- Earliest claimed: 2021-05-04
- Assignees: Janssen Pharmaceuticals, Inc.
- Applicants: Janssen Pharmaceuticals, Inc.
- Inventors: Mark Schmidt; Vanina Popova; Adam Savitz; Rama Melkote; Wayne C. Drevets; Srihari Gopal; Darrel Pemberton; Chakradhar Lagishetty; Iva Kezic
- Web page: https://patentgrep.com/patent/US11998525B2

## CPC

- A61K 31/40: having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K 9/0056: {Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals}
- A61P 25/24: Antidepressants
- A61K 9/00: Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The disclosure provides methods for treating major depressive disorder in a human patient having moderate or severe anhedonia. The methods comprise administering to the patient in need thereof an effective amount of aticaprant, or a pharmaceutically acceptable salt thereof. In some embodiments, the patient had an inadequate response to other antidepressant therapy prior to treatment with aticaprant. In other embodiments, the other antidepressant therapy comprised a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), or a combination thereof.

## Claims

### Claim 1

A method for treating major depressive disorder in a human patient, comprising administering to the patient in need thereof an effective amount of aticaprant, or a pharmaceutically acceptable salt thereof, wherein the patient had an inadequate response to other antidepressant therapy prior to treatment with aticaprant, or a pharmaceutically acceptable salt thereof, and wherein the patient does not experience a decrease in sexual functioning during the treatment with aticaprant, or a pharmaceutically acceptable salt thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the sexual functioning of the patient is assessed at the time of initial administration of the aticaprant, or a pharmaceutically acceptable salt thereof.

### Claim 3 (depends on 1)

The method of claim 1, wherein the sexual functioning comprises sexual drive, sexual arousal, vaginal lubrication, erection, orgasm achievement, or orgasm satisfaction.

### Claim 4 (depends on 1)

The method of claim 1, wherein sexual functioning is assessed by the Arizona Sexual Experience Scale (ASEX).

### Claim 5 (depends on 1)

The method of claim 1, wherein the other antidepressant therapy comprised one or more antidepressants.

### Claim 6 (depends on 5)

The method of claim 5, wherein the one or more antidepressants of the other antidepressant therapy comprised a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), or a combination thereof.

### Claim 7 (depends on 1)

The method of claim 1, further comprising treatment with an effective amount of one or more antidepressants.

### Claim 8 (depends on 7)

The method of claim 7, wherein the one or more antidepressants is a selective serotonin reuptake inhibitor (S SRI), serotonin-norepinephrine reuptake inhibitor (SNRI), or a combination thereof.

### Claim 9 (depends on 1)

The method of claim 1, wherein the aticaprant is S-aticaprant, or a pharmaceutically acceptable salt thereof.

### Claim 10 (depends on 1)

The method of claim 1, wherein the effective amount of the aticaprant is about 2 to about 35 mg.

### Claim 11 (depends on 7)

The method of claim 7, wherein the effective amount of the aticaprant is about 2 to about 35 mg.

### Claim 12 (depends on 10)

The method of claim 10, wherein the effective amount of the aticaprant is about 10 mg.

### Claim 13 (depends on 11)

The method of claim 11, wherein the effective amount of the aticaprant is about 10 mg.

### Claim 14 (depends on 1)

The method of claim 1, wherein the aticaprant, or a pharmaceutically acceptable salt thereof, is administered orally.

### Claim 15 (depends on 11)

The method of claim 11, wherein the aticaprant, or a pharmaceutically acceptable salt thereof, is administered orally.

### Claim 16 (depends on 13)

The method of claim 13, wherein the aticaprant, or a pharmaceutically acceptable salt thereof, is administered orally.

### Claim 17 (depends on 1)

The method of claim 1, wherein the aticaprant, or a pharmaceutically acceptable salt thereof, is administered once daily.

### Claim 18 (depends on 11)

The method of claim 11, wherein the aticaprant, or a pharmaceutically acceptable salt thereof, is administered once daily.

### Claim 19 (depends on 13)

The method of claim 13, wherein the aticaprant, or a pharmaceutically acceptable salt thereof, is administered once daily.

### Claim 20 (depends on 16)

The method of claim 16, wherein the aticaprant, or a pharmaceutically acceptable salt thereof, is administered once daily.

### Claim 21 (depends on 6)

The method of claim 6, wherein about 10 mg of aticaprant is administered orally, once daily.

### Claim 22 (depends on 21)

The method of claim 21, further comprising treatment with an effective amount of one or more antidepressants.

### Claim 23 (depends on 22)

The method of claim 22, wherein the one or more antidepressants is a SSRI, SNRT, or a combination thereof.

### Claim 24 (depends on 3)

The method of claim 3, wherein about 10 mg of aticaprant is administered orally, once daily.

### Claim 25 (depends on 24)

The method of claim 24, further comprising treatment with an effective amount of one or more antidepressants.

### Claim 26 (depends on 25)

The method of claim 25, wherein the one or more antidepressants is a SSRI, SNRT, or a combination thereof.

### Claim 27 (depends on 26)

The method of claim 26, wherein the other antidepressant therapy comprised one or more antidepressants.

### Claim 28 (depends on 27)

The method of claim 27, wherein the one or more antidepressants of the other antidepressant therapy comprised a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), or a combination thereof.

### Claim 29 (depends on 3)

The method of claim 3, wherein the sexual functioning comprises vaginal lubrication, erection, orgasm achievement, or orgasm satisfaction.