# US 12,594,270 B2 · Schizophrenic disorder treatment using combination therapy

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- Number: US 12,594,270 B2
- Document ID: US12594270B2
- Status: Granted
- Kind: B2
- Application number: 17/755,084
- Filed: 2020-10-21
- Published: 2022-11-03
- Granted: 2026-04-07
- Earliest claimed: 2019-10-21
- Assignees: Cambridge Cognition Limited
- Applicants: Cambridge Cognition Limited
- Inventors: Kiri Granger; Jennifer Barnett
- Web page: https://patentgrep.com/patent/US12594270B2

## CPC

- A61K 31/465: Nicotine; Derivatives thereof
- A61K 31/46: 8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
- A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61P 25/18: Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
- 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 present specification disclose a combined therapy comprising one or more activators of an alpha-7 nicotinic acetylcholine receptor activity having 5-HT3 receptor inhibitory activity and one or more activators of 5-HT3 receptor activity for use in treating a schizophrenic disorder as well as methods of treating a schizophrenic disorder by administering a combined therapy comprising one or more activators of an alpha-7 nicotinic acetylcholine receptor activity having 5-HT3 receptor inhibitory activity and one or more activators of 5-HT3 receptor activity.

## Claims

### Claim 1

A method of treating a schizophrenic disorder by administering a combination therapy comprising Tropisetron and Varenicline.

### Claim 2 (depends on 1)

The method of claim 1, wherein the Tropisetron and Varenicline are provided in a therapeutically effective amount.

### Claim 3 (depends on 2)

The method of claim 2, wherein the therapeutically effective amount of Tropisetron and Varenicline is one where the amount of Tropisetron is a suboptimal therapeutic amount when administered alone and the amount of Varenicline is a suboptimal therapeutic amount when administered alone.

### Claim 4 (depends on 1)

The method of claim 1, wherein the combination therapy comprises administration of a first composition comprising Tropisetron and a second composition comprising Varenicline.

### Claim 5 (depends on 1)

The method of claim 1, wherein the combination therapy comprises administration of a single composition comprising Tropisetron and Varenicline.

### Claim 6 (depends on 2)

The method of claim 2, wherein the therapeutically effective amount is between about 2 mg to about 75 mg of Tropisetron and between about 0.25 mg to about 4 mg of Varenicline.

### Claim 7 (depends on 2)

The method of claim 2, wherein the therapeutically effective amount is between about 5 mg to about 50 mg of Tropisetron and between about 0.5 mg to about 2 mg of Varenicline.

### Claim 8 (depends on 2)

The method of claim 2, wherein the therapeutically effective amount is between about 2 mg to about 50 mg of Tropisetron and between about 0.5 mg to about 4 mg of Varenicline.

### Claim 9 (depends on 3)

The method of claim 3, where the suboptimal therapeutic amount is less than 80%, less than 75%, less than 70%, less than 60%, less than 55%, or less than 50% of an optimal therapeutic effective amount of Tropisetron or Varenicline.

### Claim 10 (depends on 1)

The method of claim 1, wherein the schizophrenic disorder is a schizophrenia, a schizophreniform disorder, a schizoaffective disorder, or a schizotypal personality disorder.

### Claim 11 (depends on 10)

The method of claim 10, wherein the schizophrenia is a disorganized schizophrenia, a catatonic schizophrenia, a paranoid schizophrenia, an undifferentiated schizophrenia, or a residual schizophrenia.

### Claim 12 (depends on 10)

The method of claim 10, wherein the schizophrenia is an ultra-high risk (UHR) or at risk mental state (ARMS) for psychosis, a first-episode psychosis, a chronic treatment responsive schizophrenia, a treatment resistant schizophrenia, or a cognitive impaired schizophrenia.

### Claim 13 (depends on 2)

The method of claim 2, wherein the schizophrenic disorder is schizophrenia, and the therapeutically effective amount is between about 2 mg to about 75 mg of Tropisetron and between about 0.25 mg to about 4 mg of Varenicline.

### Claim 14 (depends on 2)

The method of claim 2, wherein the schizophrenic disorder is treatment resistant schizophrenia, and the therapeutic effective amount is between about 2 mg to about 75 mg of Tropisetron and between about 0.25 mg to about 4 mg of Varenicline.

### Claim 15 (depends on 2)

The method of claim 2, wherein the schizophrenic disorder is a cognitive impaired schizophrenia, and the therapeutic effective amount is between about 2 mg to about 75 mg of Tropisetron and between about 0.25 mg to about 4 mg of Varenicline.

### Claim 16 (depends on 13)

The method of claim 13, wherein the therapeutic effective amount is between about 2 mg to about 50 mg of Tropisetron and between about 0.5 mg to about 4 mg of Varenicline.

### Claim 17 (depends on 13)

The method of claim 13, wherein therapeutic effective amount is between about 5 mg to about 50 mg of Tropisetron and about 0.5 mg to about 2 mg of Varenicline.

### Claim 18 (depends on 14)

The method of claim 14, wherein the therapeutic effective amount is between about 2 mg to about 50 mg of Tropisetron and between about 0.5 mg to about 4 mg of Varenicline.

### Claim 19 (depends on 14)

The method of claim 14, wherein therapeutic effective amount is between about 5 mg to about 50 mg of Tropisetron and about 0.5 mg to about 2 mg of Varenicline.

### Claim 20 (depends on 15)

The method of claim 15, wherein the therapeutic effective amount is between about 2 mg to about 50 mg of Tropisetron and between about 0.5 mg to about 4 mg of Varenicline.

### Claim 21 (depends on 15)

The method of claim 15, wherein therapeutic effective amount is between about 5 mg to about 50 mg of Tropisetron and about 0.5 mg to about 2 mg of Varenicline.
